Design Quality Engineer II - Defined Term

Boston Scientific•San Jose, CA

4d•$81,800 - $155,400•Hybrid

About The Position

Boston Scientific has two exciting Design Quality Engineer II - Defined Term opportunities, with roles available in Valencia, CA, and San Jose, CA. These are defined-term positions lasting up to 24 months. Defined-term employees are eligible for most benefits, including paid vacation, 401K matching, and healthcare benefits. The Neuromodulation Design Quality Engineer II roles will be part of high-performing, cross-functional product development teams focused on designing world-class Neuromodulation Systems. These roles support Neuromodulation division products and involve collaboration with various cross-functional and cross-site teams. Key responsibilities include supporting Design Activities, Risk Management, and Post-Market Surveillance processes. Boston Scientific has been recognized as a top employer for engineers and a great place to work, reflecting a culture where engineers perform meaningful work and experience a positive environment. These roles follow a hybrid work model, requiring employees to be in the local offices at least three days per week. Relocation assistance and visa sponsorship are not available for these positions.

Requirements

Bachelor’s degree in mechanical, industrial, electrical, or biomedical engineering, or in another related technical discipline.
Minimum of two (2) years of professional experience in manufacturing, design, risk management, design assurance, post-market quality, and/or design engineering.
Experience in medical device industry or similar, highly-regulated industry.
Ability and willingness to work in a defined-term role for up to 24 months.
Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics.
Strong communication and analytical skills.
Ability to effectively work and collaborate in a mixed onsite and remote environment.
Demonstrated cross-functional teamwork in a technically demanding environment.
Ability to travel up to 10%.

Nice To Haves

Bachelor’s degree in mechanical, industrial, electrical, or biomedical engineering.
Advanced degree in engineering.
ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
Proven ability to influence without authority.
Quality engineering certification(s) (ASQ, CQE, CQA, etc.).

Responsibilities

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Act as an effective team member and mentor in supporting quality disciplines, decisions, and practices.
Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes.
Own, create, maintain, and/or support safety risk management processes, including Hazard Analysis, Risk Management Plan, Risk Management Report, and DFMEA.
Support Post-Market activities, as necessary, of risk based on post-market signals.
Consult with product experts, design engineering, post-market quality, and medical safety functions in a highly cross-functional organization for risk analysis across the life of Boston Scientific Neuromodulation products.
May provide support to Design Quality Engineers on new product development, acquisitions, and sustaining engineering projects.
Perform quality trending using the complaint and NCEP/CAPA systems; perform and/or lead risk analyses for CAPA and/or audit findings investigations.
Serve as a good team member, fully motivated to achieve and demonstrate best practices in line with the division’s objectives.