Principal Design Quality Assurance Engineer - Electrophysiology

About The Role

The Principal Design Quality Assurance Engineer will lead quality function for product development teams and sustaining projects for Boston Scientific’s electrophysiology cardiovascular products portfolio. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices that meet BSC, customer, and regulatory requirements.

This hybrid role is based in Waltham, MA, and requires on‑site presence at least three days per week.

Relocation assistance is available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• 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 (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 (CAPAs);
  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 (Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.).
• Engage 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 complex systems.
• Collaborate within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Build quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Perform other duties as necessary or required by the organization.

• Bachelor’s of Science 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.
• Experience working in a regulated environment (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%.

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

Minimum Salary: $106,800
Maximum Salary: $202,900

Compensation will be commensurate with level of experience and training. Salary will vary based on actual location and other factors. Variable compensation, annual bonus target, and long‑term incentives may apply depending on role classification.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company takes steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

This role is safety‑sensitive and requires a prohibited substance test. Candidates may be required to provide proof of COVID‑19 vaccination status depending on location and role. Employee vaccination and substance testing requirements may change with company policies and applicable law.