Mechanical Engineer-arden Hills, Minnesota-Hybrid

Responsibilities include:
Identifying gaps in the acquired company's DHF to Boston Scientific Work Instructions and SOPs and contributing to strategy to close these gaps, specifically on a trial nerve stimulator device for overactive bladder.
Providing input to project goals and progress and recommending appropriate revisions.
Communicating progress, risks, and trade-offs of technical deliverables to project leadership and recommending revisions as needed.
Successfully completing engineering work in one or more of the following: Device Requirements Design FMEA; Design Verification test method; test method validation; DV protocol, testing, and report; Essential Design Output identification; and requirements tracing,
Completing clear and concise engineering documentation, including protocols, reports, and rationales.
Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.

Required Qualifications:
BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
Plus 4+ yrs of medical device engineering experience. IF MS degree, 2+ years of experience.
Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
Personal drive, individual accountability & a strong bias for action
10% travel to California site (Irvine, CA) -- twice during assignment.

Preferred Qualifications
Familiarity with IEC 14708 and 45502 Active Implantable standards
Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections
DMAIC problem-solving skills
Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab
Experience in single-use device or active implantable test methods and test method validation
Ability to build strong relationships across the organization and with external stakeholders

General Comments

PR up to 58. 8-430