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Boston Scientific · 2 months ago

Principal Design Quality Assurance Engineer

Cambridge, MA

Full-time

Hybrid

Senior Level, Lead/Staff

$104K/yr - $197K/yr

10+ years exp

Boston Scientific is a leader in medical science committed to solving important health industry challenges. The Principal Design Quality Assurance Engineer will lead quality functions for product development teams, ensuring compliance with quality requirements while developing innovative cardiovascular products. This role requires collaboration with cross-functional teams and expertise in quality engineering methodologies.

Health CareMedicalMedical Device

No H1B

Responsibilities

Lead Quality function for product development teams within the BSC Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) as part of a core group of Design Quality Assurance (DQA) Engineers

Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling)

Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions

Lead Risk Management processes for new products with key inputs from cross-functional product development teams (i.e. Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.)

Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME)

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

Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements

Builds quality into all aspects of work by maintaining compliance to all quality requirements

Support internal and external regulatory audits as required

Other duties as necessary or required by the organization

Qualification

Medical Electrical EquipmentVerificationValidationRegulatory StandardsStatistical ConceptsRisk ManagementTeam Building SkillsLeadership SkillsCommunication SkillsMentoring Skills

Required

B.Sc in Biomedical, Electrical Engineering or equivalent

10 years of medical device engineering experience, with experience in Medical Electrical Equipment/Systems (MEE / MES)

Applied knowledge in the verification and validation of Capital Equipment, including hardware, software, firmware, and systems of systems interdependencies

Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485

Strong leadership, relationship building, and team building skills

Demonstrated ability to mentor and coach others in analysis and risk based decision-making processes to balance business and compliance needs

Strong communication and presentation skills

Strong applied knowledge of statistical concepts, tools, and methodologies

Travel approximately 5-10%

Preferred

Experience with Software as a Medical Device (SaMD) and/or systems integration

Benefits

Relocation assistance is available for this position at this time.

Compensation may 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 may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).