Principal Design Quality Assurance Engineer - Electrophysiology

Principal Design Quality Assurance Engineer

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

The Principal Design Quality Assurance Engineer will bring their leadership to 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.

This hybrid role is based in Arden Hills, MN and requires being on-site at least three days per week.

No 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.

Your responsibilities include:

• Lead Quality function for product sustaining teams within the BSC Quality System for Medical Electrical Equipment (MEE) and single use device (SUD) 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.
• Create, maintain and/or support safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, and DFMEA.
• Lead projects as a DQA SME and work with R&D Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Responsible for collaborating within teams to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Building quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Mentor and provide design related technical guidance within the design assurance team.
• Other duties as necessary or required by the organization.

What we're looking for in you:

• 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 design verification and validation of Capital Equipment, including hardware, software, firmware.
• 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%.

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) 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.