Vacancy expired!
- Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
- Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
- Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
- Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
- Other incidental duties assigned by Leadership
- Manage or assume functional responsibility for large projects or multiple smaller projects.
- May supervise other Engineers or manage other resources (external partners, contracts, budgets, etc)
- Demonstrate project ownership and accountability for project results.
- Develop working relationships outside of department, cross functionally.
- Think strategically as it pertains to a given project.
- Perform gap analysis on existing documents, assess, and revise to current QMS DHF and DMR documents requirements. This includes design, process, risk management, and other quality system documents.
- Work with cross-functional team (Complaints Engineering, Clinical, Product Safety Quality, R&D, Regulatory, etc) to resolve complex engineering gaps and concerns found during the remediation or .
- Perform other duties and responsibilities as assigned
- Bachelor's Degree in Engineering or Scientific field
- 2 years years experience Required or Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required.
- High Level of Proficiency in medical device Quality, Regulatory or R&D experience is preferred.
- Experience in one or more of the following is required: Design control, auditing, design review, process development and control, sterilization, or project management (i.e., product development team participation)
- Problem solving and process improvement skills a must.
- Effective communication and writing skills are required.
- Ability to work well both independently and as a member of a team is essential.
- Strong analytical and skills are preferred.
- Must be legally authorized to work in the U.S.
Vacancy expired!