Senior Process Engineer jobs
West Pharma Senior Analyst Internal Audit United States, Pennsylvania
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- Develops and implements policies and procedures for production operations
- Plans, examines, analyzes, and evaluates production operations
- Prepares production reports, reviews operating and financial data and makes recommendations for improvements
- Evaluates work performance and initiates personnel actions such as recruitment, selection, promotions, transfers, and disciplinary measures
- Resolves grievances, investigates customer complaints, and proactively participates in problem resolution
- Directs and coordinates work and production schedules and general department activities through subordinates
- Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment
- All interactions, workflow, productivity levels, and quality standards are implemented with a “Customer Service” approach to both internal and external customers
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
- Exhibits regular, reliable, punctual and predictable attendance
- Other duties as assigned
- Commercial leadership and management of the customers allocated, including full PandL responsibility for all operational aspects
- Lead and drive the highest standards in operational performance in the development, tracking and reporting of business key performance indicators
- Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).
- Bachelor's Degree in relevant engineering discipline required and
- Master's Degree in relevant engineering discipline preferred
- Minimum 8 years related experience required
- 5-10 years of experience working with injection molding processes preferred
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.
- Strong analytical and problem solving skills
- Excellent commercial acumen and customer relationship building skills
- An ability to lead in matrix structure multiple projects on-time to budget
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MongoDB Senior Software Engineer Atlas Clusters Security United States, New York, New York
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- Build and design new features for MongoDB Atlas
- Contribute to and lead complex technical projects
- Work closely with product and design teams, considering the user’s perspective while building technical solutions
- Work with customers and support engineers to fix issues
- Collaborate with team members to develop our codebase, best practices, and design principles
- Learn from and mentor other team members
- Has at least 5 years of professional software development experience
- Is skilled at writing large-scale, distributed backend systems in a compiled language (Java, C#, Go, etc.)
- Is comfortable working across the stack of a modern web application (e.g. React, TypeScript)
- Has experience with at least one major cloud provider technology (AWS, Azure, GCP)
- Has led the launch of a new module and maintained it in production
- Is eager to solve tough problems
- Has excellent communication skills
- Is curious, collaborative, and motivated
- In 3 months, you'll have shipped code into production and collaborated with the team to solve tough problems
- In 6 months, you'll have contributed to a large project
- In 12 months, you'll have designed new features, led development work, and become a go-to expert on parts of the system
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West Pharma Senior Process Engineer United States, Pennsylvania
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- Initiate, lead and coordinate improvements of existing processes globally on quality, service, HSE and cost within the standard known/approved process frame and using best practice knowledge
- Strongly support the implementation / roll-out of automation and new innovative processes and technologies in joint cooperation with the automation, engineering- and quality assurance teams and the plants.
- Manage the development of robust process for final industrial production in targeted plants.
- Assess current process status in all relevant West locations globally, define best practices, perform a gap analysis and manage the harmonization of this best practice to all sites involved.
- Engage in solutioning product or process related issues as needed.
- Support the introduction, start-up and validation of new equipment in the local sites.
- Support process or technology or product transfer projects between plants from a process stand-point.
- Evaluate and approve all change requests globally.
- Utilize six sigma tools in minimizing process variation and improving the quality of product produced.
- Bachelor's or Master's Degree in Engineering or another scientific area or equivalent experience required
- Minimum 3 years experience in a similar position within the manufacturing industry required
- Experience in Project Management preferred
- Good knowledge of LEAN and Six Sigma manufacturing principles (Green Belt certification)
- Knowledge of MS Office, statistical tools and Minitab
- cGMP knowledge
- Fluent English and German skills
- Self motivated, result- and solution-oriented personality
- Excellent communication skills
- Ability to successfully collaborate with teams across different countries and organizational levels
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West Pharma Senior Regulatory Affairs Specialist United States, Pennsylvania, West Whiteland Township
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The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.
- Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
- Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
- Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
- Provide leadership to cross functional teams for regulatory issues and questions.
- Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
- Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
- Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
- Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
- Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
- Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required
- Bachelor’s degree or equivalent experience is required
- Master’s degree or PhD in science, math, engineering, or related discipline preferred
- Minimum 5 years of relevant experience
- 2+ years of medical device regulatory experience preferred
- Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
- History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
- Advanced knowledge of ISO 13485
- Advanced knowledge of product life cycle, product development process, design control and change control
- Experience interacting with government agencies
- Excellent oral communication, technical writing, and decision-making skills
- Attention to detail with planning, time management and organizational skills
- Regulatory compliance competency including Quality Systems
- Experience with administration and safety systems preferred
- Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.
- Ability to comprehend principles of math, science, engineering, and medical device use.
- Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
- Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
- Ability to review, collate, describe, and summarize scientific and technical data.
- Ability to organize complex information and combine pieces of information to form general rules or conclusions.
- Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
- Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
- Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
- Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
- Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
- Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
- Ability to verbally communicate ideas and issues effectively to other team members and management.
- Ability to write and record data and information as required by procedures.
- Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
- Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
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Boston Scientific Quality Engineer II United States, Minnesota
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About the Role:
In this dynamic production environment, they have the opportunities to develop, establish and maintain quality engineering methodologies, systems, and practices. Serving as representatives of the Quality organization, they will improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
Your Responsibilities Include:
- Partners with Manufacturing Engineering and Production core team members for daily manufacturing line support decisions and practices.
- Collaborates with cross-functional team to evaluate manufacturing results, assist defect detection, primary cause identification, and understanding corrective and preventative actions.
- Identifies and implements effective process control systems to support the development, qualification, validation and verification to meet or exceed internal, external, and regulatory requirements.
- Supports a culture of continuous improvement by advancing improvements to existing processes and controls.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Broadly engages with production teams across all shifts to develop and support solutions to improve outgoing quality.
- Provide task direction, coaching, and mentorship for technician team members.
- Participate in team decision-making and display team problem-solving/communication skills.
What We’re Looking For:Required Qualifications:
- Bachelor’s degree in engineering, technology, mathematics, or related science
- 2+ years of relevant experience in a regulated industry
- Strong verbal and written communications skills; Good documentation practices
- Works effectively in a Controlled Environment Area (CEA) manufacturing environment
- Self-starter with a proven ability to successfully work with minimal supervision
- Knowledge of basic Quality Management Systems
- Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)
Preferred Qualifications:
- Medical device experience
- Comfortable with utilizing analytical equipment (including microscopes)
- Strong analytical skills, problem solving, and statistical analysis (Excel, Minitab)
- Experience with the following disciplines: manufacturing/process engineering, post-market complaints, supplier quality, CAPA, risk management
- Experience running/owning nonconforming event risk assessments and investigations
- Proficient using manufacturing control software (various MES, MasterControl, etc.)
- Project management experience
Maximum Salary: $ 132000
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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Boston Scientific Senior Packaging Engineer United States, Minnesota
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Your responsibilities include:
- Perform all aspects of the monthly financial close including generation of monthly and quarterly management reporting and variance/trend analysis
- Supports the annual planning process for the functional areas of responsibility including coordinating with the various functional groups to develop operating expense budgets and providing analytical support to identify key business drivers
- Analysis and submission of functional budgets
- Support decision-making process to enable profitable growth
- Support regular and adhoc reporting and presentations to management
- Identify and drive cost saving opportunities across the SG&A functions
- Quickly respond to numerous ad hoc queries from internal customers (including Senior Management)
Minimum Qualifications:
- Bachelor’s degree in Finance or Accounting
- 5+ years of relevant FP&A experience
- MS Excel and PowerPoint required, financial tools (Hyperion (Oracle), SAP) preferred
- Excellent oral and written communication skills
- Strong financial analysis, communication, organizational and prioritization skills
- Strong attention to detail and data accuracy
Preferred Qualifications:
- Ability to multi-task and set priorities/execute in a high-paced organization
- Ability to work in a dynamic environment, adhere to tight deadlines
- Team orientated
- Must have a process improvement mindset and strong problem-solving skills
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
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Boston Scientific Senior Meeting Planning Specialist United States, Minnesota
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About the role:
This position is responsible for the strategic planning and execution of PI Vascular Medical Affairs and Professional Education meetings.
Your responsibilities will include:
- Manage program logistics including sleeping rooms, flights, food and beverage, ground transportation, meeting room set-up, budgets, attendee management, communications, and onsite materials.
- Build and manage event registration processes using Cvent, ensuring accurate data management, providing attendee support, generating reports, and collaborating with cross-functional teams for seamless event execution.
- Manage surveys and evaluate feedback from the training programs and working closely with the Program Mangers to make changes to our current programs to ensure use of both best practice and new innovative education methods.
- Ensures consistency and collaboration for meetings while following established guidelines, processes, and tools.
- Defines, tracks, and maintains budgets while ensuring cost-saving measures and spending are within allocated amounts.
- Maintains and enhances knowledge of the meetings & events industry trends and best-in-class practices.
- Partners with and manages vendors to ensure objectives are being met.
- Runs reports and presents data metrics to leadership for all Medical Affairs & Ed as requested.
- Planning and coordinating other projects that contribute to the accomplishment of the clinical education goals and objectives
- Communicates proactively to stakeholders across all levels of the organization.
- Educates cross-functional teams, provides direction, and establishes solutions where appropriate.
- Ensures all company policies and compliance practices are being followed.
Required qualifications:
- Bachelor’s degree or equivalent
- A minimum of 5 years of related experience in event/meeting planning
- Proven history of working on international HCP programs and outside of the US compliance policies.
- Candidate must have appetite for innovation and continuous learning.
- Ability to develop and maintain relationships with physician customers and sales teams.
- Works independently on complex meetings
- Must be a strong communicator and collaborator
- Ability to develop new processes and adjust practices to meet business needs.
- Strong organizational and multitasking skills with meticulous attention to detail.
- Ability to handle high volume workload and fast pace; manage stress
- Strong project management and organization skills; detail-oriented
- Proficient in the use of Microsoft Office Suite, Cvent and SalesForce.com
- Domestic travel required up to 20%
- Ability to lift 20lbs
- Ability to work extended hours/weekend hours, as needed
Preferred qualifications:
- Experience in the medical device industry
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
These jobs might be a good fit
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- Develops and implements policies and procedures for production operations
- Plans, examines, analyzes, and evaluates production operations
- Prepares production reports, reviews operating and financial data and makes recommendations for improvements
- Evaluates work performance and initiates personnel actions such as recruitment, selection, promotions, transfers, and disciplinary measures
- Resolves grievances, investigates customer complaints, and proactively participates in problem resolution
- Directs and coordinates work and production schedules and general department activities through subordinates
- Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment
- All interactions, workflow, productivity levels, and quality standards are implemented with a “Customer Service” approach to both internal and external customers
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
- Exhibits regular, reliable, punctual and predictable attendance
- Other duties as assigned
- Commercial leadership and management of the customers allocated, including full PandL responsibility for all operational aspects
- Lead and drive the highest standards in operational performance in the development, tracking and reporting of business key performance indicators
- Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).
- Bachelor's Degree in relevant engineering discipline required and
- Master's Degree in relevant engineering discipline preferred
- Minimum 8 years related experience required
- 5-10 years of experience working with injection molding processes preferred
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.
- Strong analytical and problem solving skills
- Excellent commercial acumen and customer relationship building skills
- An ability to lead in matrix structure multiple projects on-time to budget
These jobs might be a good fit
