Medical Device Assembler Defined Term - Shifts jobs at Boston Scientific

This is a defined term position with an expected duration of 1 year.

Your responsibilities will include:

• Identifying the opportunities for continuous improvement and initiates activities to support the improvement process.
• Leading quality projects of major magnitude and scope.
• Providing significant guidance and approval regarding technical strategies and approaches.
• Managing and providing direction to quality engineers on professional, personnel issues, and provides development opportunities.
• Providing guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
• Participating on team projects and assignments, facilitating or leading teams as necessary.
• Determining project staff assignments and schedules work to meet completion dates and deliverables.
• Working cross-functionally in identifying and resolving technical issues.
• Driving and evaluates project and department progress and results.
• Providing guidance and decisions on Operations and Design Control activities to ensure continued compliance with internal BSC procedures, and applicable regulatory and international standards as defined in the BSC Quality Policy and site Compliance Matrix.

Required qualifications:

• Bachelor degree
• Minimum of 7 years experience in medical device or similar regulated industry
• Minimumof 4 years leading cross functional teams in a technical field
• Able to travel 1-2 times a year

Preferred qualifications:

• More than 10 year of experience in Medical Devices or similar regulated industry
• Higher education MBA, MS in science or engineering
• Neuromodulation device experience, capital equipment experience
• Experience working with TUV, BSI, FDA etc
• Boston Scientific experience

Maximum Salary: $ 243000

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.

The primary focus is to build a quality product by following processes to meet all production goals.

Your responsibilities will include:

• Understands and adheres to safety policies and practices.
• Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy, and the Strategic Quality Process (SQP).
• Builds product by following all processes in which certified (in their most current revision), and completes other assigned work, while meeting manufacturing goals and metrics.
• Gains a basic understanding of Lean Manufacturing and related principles.
• Willing to flex and rotate as necessary and work well with all group members, both within the team and cross-functionally.
• Under the direction of other maintains accurate records such as Shop Floor Paperwork (SFP), training Records System (TRS), Product Data Management (PDM), Systems Application & Products (SAP), and Process Equipment Optimization (PEO).
• Moderate mechanical aptitude. Able to learn how to set up equipment to meet process specifications.
• Under the direction of others interprets quality specifications via SPC; understands tight tolerancing through the use of various measurement equipment.
• Assist and learn to take ownership and accountability to drive metrics by actively participating in Focused Factory cross-functional teams.
• Understands and follows all BSC and site-specific policies and procedures.
• Responsible for attending and passing all core required BSC and site-specific training (i.e. QS Basics, RTK, Lean Training, Extrusion 101).
• Demonstrate an understanding of the basic functions of SAP.
• Able to perform basic extrusion troubleshooting methods.
• Learns to plan and prepare the equipment to meet the customer’s requirements.
• Provide CI suggestions.

Required qualifications:

• 1 year of experience with a High school diploma/degree/equivalent

Preferred qualifications:

• Previous machine operation experience / mechanical minded preferred

3rd shift hours: Sunday through Thursday 9:30PM to 5:30 AM

Shift times vary by half an hour

About the role:

Primary focus is to build product by following processes to meet production goals.

Your responsibilities will include:

• Understands and adheres to safety policies and practices.
• Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy and the Strategic Quality Process (SQP).
• Builds product by following all processes in which certified (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics.
• Demonstrates and applies a solid understanding of Lean Manufacturing and related principles.
• Knows and applies flex strategy, rotates as necessary and works well with all group members, both within the team and cross-functionally.
• Maintains accurate records, including training files and shop floor paperwork (SFP).
• Willingly participates in Shared Responsibility and continuous improvement teams.
• Understands and follows all BSC and site-specific policies and procedures.
• Responsible for attending and passing all required core BSC and site-specific training (i.e. QS Basics, RTK, Lean Training).
• Performs routine functions of SAP specific to the area (i.e. e-kanban boards, issuing/de-issuing, confirmations).
• Willing to become a Certified Back-Up Trainer (CBT) as determined by the supervisor. If acting as a CBT, responsible for training others and maintaining accurate training files for others. Actively involved in monitoring and maintaining accurate SFP.

Required qualifications:

• High School Diploma or equivalent
• Minimum of 2 years of work experience in manufacturing is required
• Previous experience in manufacturing, performing inspections, operating equipment
• Experience with Lean Manufacturing and related principles
• Experience with maintaining accurate records including training files and shop floor paperwork
• Experience with SAP or other manufacturing execution software programs
• Experience training others

Preferred qualifications:

• 5 years of work experience in manufacturing is preferred
• Previous medical device experience preferred, but not required

This position requires proficiency in communication and understanding of English, including reading work instructions to consistently build defect free medical products.

Maximum Salary: $54,808

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.

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.

Your responsibilities will include:

• Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements.
• Demonstrate a primary commitment to patient safety and product quality.
• Under direction and mentorship of senior staff completes biocompatibility evaluations and safety assessments as necessary to support business objectives.
• Provides input on the regulatory requirements related to medical device submissions, on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs.
• May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, color additives, exposure assessments of chemicals, and other chemical toxicities as assigned.
• Communicates with internal customers on biocompatibility and toxicology issues, supports problem solving and resolution related to related to biocompatibility assessments, chemical characterization, and toxicological risk assessments.
• Participates as assigned in training for functional groups of device development teams based on standards and regulatory requirements.
• Provides input on biocompatibility, chemistry and toxicology testing related to new investigational and strategic device development programs.

Required qualifications:

• A BS / MS degree in Toxicology is preferred, or closely related field (biology, chemistry, biochemistry, biomedical engineering).
• 2+ years’ experience supporting medical devices.
• Excellent written and verbal communication skills.
• Results and detail-oriented.
• Able to multi-task while working against aggressive timelines.
• Comfortable in a dynamic environment and able to work independently as well as on teams.

Preferred Qualifications:

• Knowledge of the biological evaluation of medical devices (ISO 10993-1) preferred. Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials.
• Working knowledge of regulatory standards and global regulatory requirements with respect to medical device.
• Experience with running GLP and non-GLP studies.

• A BS / MS degree in Toxicology is preferred

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.

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.

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.

Your responsibilities will include:

• Develop and implement sales strategies by determining the relevant factors (e.g., product, competition, and pricing needs) of existing and potential accounts to effectively promote the company's products to appropriate hospital personnel and physicians.
• Develop action plans (i.e., weekly, quarterly, monthly) by analyzing quarterly and monthly sales figures and reports identifying the needs of particular accounts and discussing issues with Regional Sales Manager to help the organization achieve its annual sales goal.
• Determine the needs (e.g., product and pricing), goals, product usage, and types of cases handled by specific customers by meeting with and asking in-depth questions of physicians and other hospital personnel.
• Establish pricing packages to establish price points that address specific customer's needs while satisfying company guidelines and policies.
• Respond to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g. clinical research, pricing and/or marketing) to develop optimal solutions.
• Develop relationships with hospital personnel (e.g. through casual conversation, meetings, participation in conferences) to make new contacts in other departments within hospital and to identify key purchasing decision makers in order to facilitate future sales.
• Educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to secure purchasing commitments, often with the help of incentive programs and services made available to the account being developed.

Required qualifications:

• Minimum of a bachelor’s degree OR equivalent field clinical/sales experience.
• Minimum of 2 years medical device, pharmaceutical, or related sales experience.

Preferred qualifications:

• Experience selling cardiac monitoring equipment or cardiac related devices.
• Direct selling experience to physicians and hospitals.
• History and relationships with key players in the cardiac monitoring industry.
• Must have a technical aptitude; be able to discuss, explain software algorithms.
• Strong interpersonal skills, requires good communication skills, both verbal and written, and able to communicate effectively with diverse groups of people (physicians, office staff, etc.).

The anticipated annualized base amount for this full time position will be$, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Work Mode:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in BSC Arbor Lakes, MN or Marlborough, MA.

Your responsibilities will include:

• Responsible for the development, in collaboration with the clinical trial team, of study-specific documents such as clinical protocol, clinical study reports and summaries, and clinical content that support the regulatory needs of a project.
• Reviews statistical output from BSC clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data.
• Responsible for the development, dissemination, and amplification of scientific clinical content in a variety of communication vehicles to ensure appropriate evaluation and presentation of data, interpretation, and alliance with business objectives.
• Writes manuscripts, as well as abstracts, slide presentations, and poster presentations for scientific meetings within and outside the U.S. in support of ICTx studies.
• Partners with internal and external authors (physicians/trial investigators) on manuscripts, conference abstracts, slide presentations and posters.
• Identifies gaps and opportunities for compelling evidence for relevant BSC products and therapies. Works with clinical and other functions (HEMA, R&D, marketing, etc) to identify solutions to the evidence gaps identified.
• Helps to organize and chair BSC study publication plan teams. Partners with investigators and internal BSC personnel to solicit feedback and develop clinical study-related publication plans. Serve as an advisor and expert for physicians needing to access relevant clinical content.
• Collaborates and provides input into clinical evidence strategy related to relevant BSC therapies.
• Interacts with marketing and other groups such as Scientific Communications to ensure that clinical data is represented accurately and correctly in any published literature, slide sets, and other materials prepared by these groups.
• Remains current with medical and scientific developments and publications on current/pipeline and competitor products, as well as maintaining a solid knowledge base of current data in relevant fields.
• Attends scientific conferences and programs in relevant therapeutic areas to maintain current knowledge.

Required qualifications:

• Minimum bachelor’s degree is required; and a minimum 3 years of experience (medical device, pharmaceutical, or biotechnology) in a related function such as clinical, research, marketing, medical affairs or product development or equivalent experience
• Proven knowledge of clinical issues associated with cardiology (structural heart, coronary therapies, and/or interventional heart failure) gained through direct or comparable relevant experience in a therapeutic area, scientific, or clinical setting
• Willingness to travel up to 10% travel domestic and international

Preferred qualifications:

• Solid understanding of scientific or clinical research and the scientific method, including interpretation of statistical results of clinical studies
• Demonstrated scientific/medical writing acumen (e.g., manuscripts, research grants, etc.)
• Ability to prepare and deliver scientific presentations, understanding of the structure and content of scientific presentations, ability to tailor presentation format and content to specific needs of topic and/or audience
• Knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices

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.

About the role:

This is a highly visible opportunity to serve as the Integration Developer delivering strategic initiatives supporting the HR function. You will own the integration development and implementation responsibilities for our SuccessFactors Integrations product team that designs, develops, tests, deploys, maintains, integrations that flow data to/from our HR platform successfactors. Partnering with HR leadership, and product management team you will be responsible for implementing and supporting various integrations. You’ll work across several globally dispersed teams on some of Boston Scientific’s most critical strategic projects. You will be instrumental in achieving our organization’s goals.

Your responsibilities will include:

• Design and implement integration flows using SAP CPI and BTP.
• Collaborate with functional and technical teams to gather requirements and translate them into integration solutions.
• Develop and maintain APIs and middleware components for HR applications.
• Monitor and troubleshoot integration issues, ensuring high availability and performance.
• Participate in code reviews, testing, and deployment activities.
• Document integration designs, configurations, and support procedures.
• Ensure compliance with data security and privacy standards.
• Ensure that the HR system and related processes meet all applicable compliance requirements
• Ensure adherence to BSC Global Systems methodology and SOX controls
• Ensure Production support tickets are handled within the agreed SLAs
• Work proactively on achieving the VIP goals set for the team.
• Support teams’ growth in Scrum/Kanban methodologies as well as conduct Scrum ceremonies to support enterprise delivery transformation model
• Provide product team reporting/dashboard(s) for senior management in a timely manner

Minimum qualifications:

• Bachelor’s degree in a related field (completed)
• 2+ year of Experience in Design and implement integration flows using SAP CPI and BTP
• 2+ years of Integration Development experience
• Experience in Product Teams and Agile SCRUM methodologies
• Advance English Level

Preferred qualifications:

• Experience in delivering results in large, cross-functional software initiatives
• Experience with SuccessFactors and data integrations processes
• Experience with SuccessFactors implementation and knowledge of different modules in SF
• Experience working on solutions in a controlled environment
• Proficiency in Microsoft Office: Word, Excel, and PowerPoint