Sr Mechanical Engineer

Job Description

The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated Mechanical Engineer to join our acquisition and integration project for a duration of ten months, with the possibility to extend. In this role, you will provide support in integrating the acquired company's Design History File to compliance, specifically for a nerve stimulation product. This role would be responsible for assessing the acquired company's design inputs, risk management, design verification, test methods, and design outputs to identify and close gaps against the quality system.

As a key team member, you will provide solutions and technical support under some guidance from our subject matter experts. You will utilize your background in mechanical and/or systems design, test method design and validation, verification testing and statistical analysis.

• Identifying gaps in the acquired company's DHF to 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.
• Taking DHF data from newly acquired company and convert it to clients compliance.
• Defining design or test requirements, run new DHF testing of commercially utilized product.
• This is not new product development (NPD), this product is already on the market.
• Pulse generators (lower back implants for overactive bladder).
• Assessing existing DHF, gap assessment, look through DFMEA and design requirements, Test methods.
• Six Sigma - Problem solving.

• BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field.
• 3+ years of medical device engineering experience.
• Strong mechanical and/or systems engineering and problem-solving skills and attention to detail.
• Gauge R&R and Minitab.
• Test Method Validation.
• DHF, DFMEA.
• Experience with change management and issue tracking tools such as JIRA, Accu Rev, Windchill etc.
• 10% travel to California site (Irvine, CA) -- twice during assignment.

• 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.