Manufacturing Engineer II
About The Position
The Manufacturing Engineer II provides engineering and project management support for designing and developing new processes and equipment, scaling up and commercializing new products, continually improving existing technologies, and optimizing and troubleshooting existing operations. The role supports the transfer of products and processes into manufacturing and helps ensure production requirements are met. The position manages equipment and process validations, including developing protocols, identifying test requirements, analyzing and presenting results, and preparing final reports in accordance with internal procedures and external regulations. It also applies Lean Manufacturing principles to improve operational measures and supports manufacturing and quality assurance teams with investigations, process controls, calibration, and preventative maintenance programs.
Requirements
- Bachelor of Science degree in Engineering.
- At least 6 years of experience in an engineering position within a medical device manufacturing organization.
- Working knowledge of Lean Manufacturing Principles.
- Strong mechanical aptitude, oral and written communication, project management, and organizational skills.
- Proficiency in CAD software, servo and/or PLC applications, and electromechanical systems.
- Thorough understanding of GMP and ISO requirements for medical device manufacturing operations and FDA-regulated quality systems, including experience with nonconformances, CAPAs, complaints, and change control.
- Authorization to work for any U.S. employer; the company is unable to sponsor or take over sponsorship of an employment visa.
Nice To Haves
- Six Sigma Green Belt Certification.
Responsibilities
- Support scale-up and development of new products and processes, including developing methods, procedures, and specifications for timely transfer to manufacturing.
- Contribute engineering expertise to continual improvement teams by developing process methods, designing or sourcing equipment, conducting feasibility and developmental trials, executing validation requirements, preparing documents, specifications, and drawings, and providing on-the-job training for product and process transfers or start-ups.
- Manage equipment and process validations, including creating protocols, identifying test requirements, analyzing and presenting results, and preparing final reports in accordance with internal procedures and external regulations.
- Apply Lean Manufacturing principles and tools to improve operational measures such as yield, cycle time, takt time, inventory, and nonconformances.
- Provide engineering support to manufacturing and QA groups to meet production requirements.
- Lead investigations involving nonconformances, CAPAs, complaints, and production troubleshooting.
- Prepare presentations and reports communicating engineering project status, progress toward goals and objectives, future opportunities, and risks or alternatives to management.
- Support development, training, and maintenance of site calibration and preventative maintenance programs and manufacturing process controls.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Disability insurance
- Life insurance
- 401(k) plan and company match
- Tuition reimbursement for select degrees
- Company holidays
- Well-being benefits
- Sick time
- Floating holidays
- Paid vacation
- Short-term and/or long-term incentives may be available
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
