Additional Location(s): US-MA-Waltham; Canada-QC-Montreal; US-MN-Arden Hills
About the roleThe Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
Work ModeAt Boston Scientific, we value collaboration and synergy. This hybrid role is based in Waltham, MA and requires being on-site at least three (3) days per week. We will also consider candidates based in our Arden Hills, MN or Montreal, Canada locations.
Relocation assistanceRelocation assistance is available for this position at this time.
Visa sponsorshipBoston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities include:- 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.
What we're looking for in you:Required Qualifications
- 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%.
Preferred Qualifications
- Experience with Software as a Medical Device (SaMD) and/or systems integration
Requisition ID: 634099Minimum Salary: $ 106800 Maximum Salary: $ 202900 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for
non-exempt (hourly), non-sales roles 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 for
exempt, non-sales roles may 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.
