Senior Manufacturer Engineer (Medical Device)

We are searching for a Senior Manufacturer Engineer 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.

The Senior Manufacturer Engineer 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:

• Develop and refine new products. Identify and improve processes and procedures.
• 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, direct, and execute process validation and equipment qualification activities.
• Responsible for the accuracy and completeness of all relevant documentation.
• Ensure that OPS programs, initiated to meet Company milestones and plans, are implemented, and reviewed for each program according to Design Control guidelines and that the planned results are realized within predetermined timeframes.
• Maintain schedules for projects and/or specific aspects of projects.
• Provide direction and guidance to the assembly team to facilitate the production of high-quality products, steady manufacturing output and high yields.
• 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 advanced 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.
• 5+ years engineering experience, preferably within the medical device or other regulated industry.
• Interpersonal and collaborative work style. Excellent written and verbal communication skills and exceptional design problem solving skills.
• Supervisory and strong motivational skills required.
• Proven ability to design complex 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.
• Physical requirements: standing, sitting, walking, stairs, light lifting, manual dexterity, operating computers. Ability to tolerate direct exposure IPA, adhesives, part cleaning solutions and other materials common to medical device production.

EOE of Minorities / Females / Vets / Disability.