The Sr. Manufacturing Engineer is responsible for maintaining, improving, and building new production capabilities and ensuring we meet quality and performance standards.

The Sr. Manufacturing Engineer will report directly to the Manufacturing Engineering Manager and have the following primary responsibilities:

• Responsible for the sourcing and installation of new equipment including IQ/OQ/PQ’s.
• Construct of work centers that enable proper and efficient assembly of medical devices.
• Develop and perform engineering studies and process validations.
• Analyze production processes and identify opportunities to improve product quality and efficiency.
• Contribute to lean manufacturing program to optimize manufacturing efficiencies.
• Develop and implement improved manufacturing processes.
• Work with vendors to address supplier issues or source new materials or components.
• Evaluate products according to specifications per associated ASTM/ISO and/or other applicable standards or requirements.
• Aid in production transfers from R&D to manufacturing.
• Generate and update production document and drawing through a paperless Engineering Change Orders (ECO’s).
• The position will require the willingness to work on the manufacturing floor (up to 50% of the time) to learn and improve upon existing and new processes.

Pay range $125,000-$135,000 per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.

• Education: Bachelor's degree (B. A.) from four-year college or university.
• Manufacturing experience with a “hands-on” ability and intuitive mechanical knowledge.
• Ability to manage a project from concept through completion.
• Travel: ~ 25% travel is required.
• Experience: 6+ years engineering experience is required. Medical Device manufacturing experience is desired but not required.
• Computer Skills: Proficient with MS office software, especially Word and Excel. Experience with SolidWorks.
• Familiarity with cGMP’s and ISO requirements is a plus.
• Biologics background is a plus as well.