Medical Device Manufacturing Engineer III

We are searching for a Medical Device Manufacturing Engineer III on behalf of our client. If you have experience in the medical device industry and have clean room experience, then this is a great opportunity for you to be part of an industry that have helped people nationwide.

This is a direct hire position with benefits.

Relocation: If a candidate is located out of the Reno area, client would offer a relocation package.

Medical Device Manufacturing Engineer III will be the project leader and primary contributor on various projects (small, medium, and large) that fall in the “gaps” between Reno R&D, OPS, and QA. Pull in other team members as necessary to drive these projects to completion. Candidates must have proven ability to design complex assembly fixtures in SolidWorks CAD.

The person will work closely with other departments and suppliers to coordinate efforts, including but not limited to, component vendors, tooling vendors, contract manufacturers, and partners. Periodic travel may be required at various points in time according to the needs of the organization.

Job Description

Essential Functions:

• Lead design reviews with cross-functional departments (R&D, QA, OPS)
• Help develop and refine new products.
• Help identify and implement process and procedure improvements.
• Actively foster and promote lean manufacturing philosophy among the team.
• Prepare product documentation including component specifications, BOMs, CAD models and drawings, Manufacturing Instructions and Lot History Records.
• Develop and maintain manufacturing equipment, tooling and fixturing.
• Write, execute and supervise test protocols, test data and test reports.
• Plan and execute process validation and equipment qualification activities.
• Originate DCOs and NCMRs. Participate in CAPAs as needs require.
• Responsible for the accuracy and completeness of all relevant documentation.
• Work closely with other departments and suppliers to coordinate efforts, including but not limited to, component vendors, tooling vendors, contract manufacturers, and partners.
• Maintain project schedules as needs require.
• Provide guidance to the assembly team to facilitate the production of high-quality products, steady manufacturing output and high yields.
• Mentor junior engineers and manage engineering interns.
• Track manufacturing production yield and throughput; identify and mitigate the impact of situations causing low yield and/or throughput.
• Develop, monitor and evaluate key performance parameters for manufacturing processes.
• Candidate shall have knowledge and experience with ophthalmic surgical equipment or similar medical devices, and familiarity with their use, technologies involved and risk management techniques.

Qualifications:

• B.S. or M.S. degree in Mechanical Engineering.
• 3+ years engineering experience, preferably within the medical device or other regulated industry.
• Interpersonal and collaborative work style. Strong written and verbal communication skills and good design problem solving skills.
• Proven ability to design intricate assembly fixtures in SolidWorks CAD.
• Materials and processing knowledge.
• GMP and ISO 13485 training.
• Strong Lean Six Sigma knowledge.
• Ability to identify problems and take corrective measures to solve them quickly and efficiently.
• Clean room experience required.

EOE of Minorities / Females / Vets / Disability.