דרושים Af Solutions Senior Clinical Specialist - Austin Tx ב-Boston Scientific

About the role:

As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; To help patients in need get back to their daily lives. As a Principal Design Quality Assurance (DQA) Engineer, you’ll be at the heart of that mission to develop and support best-in-class products to bring advanced, safe innovations to the clinic. You will also be leading the effort to develop MEE /

Your responsibilities include:

• Lead product teams within the BSC Quality System to develop new MEE and MES as part of a core group of DQA Engineers supporting the Laser Therapies franchise. Special focus on:
• Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
• Utilize Systems Engineering practices to lead efforts for requirements management/system architecture to align risk mitigations with design inputs, design outputs at different levels (e.g., system / sub-system) for products that are both stand alone, and network connected.
• Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Lead Risk Management activities during all phases of Electrical HW/SW design, using design quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
• Participate and lead in the creation and maintenance of Risk Management and Usability deliverables.
• Lead and/or support development of NPD Reliability Engineering Program Plans and related reliability program activities.
• May perform other duties as directed.

Minimum Qualifications

• B.Sc in Biomedical, Electrical Engineering or equivalent.
• 7-8 years of Medical device engineering experience, with experience inMedical Electrical Equipment/Systems (MEE / MES).
• Experience with Reliability and Systems Engineering principles
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971 and EN ISO 13485.
• Strong leadership skills.
• Hands on team player.
• Coaches others in analysis and decision making. Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and/or other electrical testing/simulation software.
• Travel approximately 5-10%.

Preferred Qualifications

• Certified Reliability Engineer and/or Systems Engineer
• Experience with Software as a Medical Device (SaMD) and/or systems integration

Your Responsibilities Include:

• Lead cross-functional project teams to the successful completion of project goals. Work includes ensuring the scope of work, schedules, costs, and risks are properly planned, resourced, and managed.
• Lead strong and agile project risk management in a dynamic and innovative R&D division.
• Support the team with all project activities, oversee risks and technical challenges, and evaluate potential solutions and their ultimate impact on the project and business.
• Creating and managing detailed plans of multidisciplinary product development for the R&D and its interfaces.
• Prioritize and manage activities among team members and project interfaces to drive successful execution of the project with a focus on R&D deliverables.
• Monitor progress, create, and provide project status and updates on a consistent basis.
• Drives results by acting with speed and agility. Eliminate blockers and act to advance areas that need improvement with the relevant stakeholders.
• Develop content that is compliant with EU MDR, US FDA global regulatory requirements, and all relevant Boston Scientific QS requirements.
• Lead project phases and gates preparation, drive transition to a new quality system.
• Manage contracts with vendors and suppliers by assigning tasks, communicating expected deliverables, and overseeing project procurement management.

• BSc/MSc in Mechanical/Electrical/Software/Biomedical Engineering or equivalent
• Over 3 years of demonstrated experience as a Project/Program Manager
• Over 5 years of demonstrated experience in R&D/new product development and multidisciplinary products (HW, SW, Mechanics, Electro-Optics)
• Leading cross-functional global teams through all project phases (including transfer to production)- preferred
• Experience in the medical device industry is highly preferred
• Excellent communication and interpersonal skills
• Strong Strategic thinking, Excellent analytical and problem-solving skills, Creative and agile mindset
• Self-starter, proactive, dynamic, highly motivated with a “can do” approach
• Fluent English
• In-depth knowledge of project management tools, methodologies, and best practices

Responsibility for sourcing and managing

Key Responsibilities

•Leading and supporting integration activities of acquired products into Boston Scientific’s systems/processes

•Build & enhance supplier relationships to drive sourcing & supplier initiatives to meet or exceed product quality, service & deliver sustainable cost reductions

•Taking role with the global Mechanical Category team.

•Management of RFQ process – analyzing & negotiation of costs, understanding TCO, identification and mitigation of risks. Making recommendations to internal stakeholders

•Partner with internal stakeholders to onboard suppliers to Boston Scientific’s quality system in a timely manner, ensuring that all activities are aligned
to Boston Scientific’s quality and commercial requirements

•Negotiation of commercial agreements either independently or in support of internal stakeholders

•Attendance at meetings - compiling data and presenting at meetings where required

•Assist with identification of gaps in processes and procedures, networking to collect process and system’s needs

•Assist with writing, reviewing and implementation of processes and procedures to build a fit for purpose process

•Seek out cost reductions with supply base year round

•Manage the annual budget process and cost setting for assigned parts/suppliers

Experience & Educational Requirements

• Bachelor’s (B.A) degree in Industrial Management or Economics- mandatory
• Minimum of 5 years in strategic sourcing- mandatory
• Minimum of 7 years' Experience with Mechanical suppliers- mandatory
• Ability to read and understand mechanical drawings - mandatory
• Experience of negotiating commercial agreements
• Training or experience with cost modeling, data analysis and negotiation
• Fluent English
• Excellent communication and collaboration skills at all levels, with both internal and external stakeholders