Principal Design Quality Assurance Engineer

Boston Scientific•Waltham, MA

About The Position

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.

Requirements

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.
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%.

Nice To Haves

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

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)
Provide quality and compliance inputs to project teams for project decisions and deliverables
Provide quality and compliance inputs for post market product sustaining activities
Lead Risk Management processes for new products with key inputs from cross-functional product development teams
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.