Senior Manufacturing Engineer
You will develop and implement optimal, and cost-effective manufacturing processes and methods in accordance with customer specifications and quality standards. You will provide process development and manufacturing engineering support as a project team member during product development phases and a project team lead during manufacturing scale up regarding the introduction of new products into manufacturing through DV builds,
- As an Engineer you will apply sound engineering judgment to problems, which may include moderate complexity and conflicting design objectives or difficult materials.
- Participate as a team member on new product development projects as the manufacturing representative to provide DFM input and preliminary process development.
- Plans and coordinates projects of moderate scope to support manufacturing scale up including estimating schedules, staffing needs, project cost and budget.
- Assumes technical ownership for assigned products and projects. * Responsible for equipment, tooling, and fixture design, development, and procurement including preparing specification’s and tests materials.
- Responsible for drafting process risk documentation including but not limited to Master Validation Plans and PFMEAs.
- * Develop and oversee the execution of process validations including but not limited to IQs, OQs, PQs, Gage R&Rs, and other engineering studies, qualifications, and/or DOEs.
- Makes independent decisions on work.
- Develops processes that meet safety regulations and adhere to ISO 13485, QSR 21 CFR 820, GMP, and other applicable requirements.
- Coordinate launches of new processes including establishing goals, training team members, and evaluating results. * Ensures compliance * Participates in Kaizen events. * Other responsibilities as required.
Bachelor's Degree in Mechanical or Manufacturing Engineering or equivalent.
* Knowledge and experience with ISO 13485, QSR 21 CFR 820, GMP, and FDA practices and requirements Skills/Competencies.
* Kaizen and Lean Manufacturing techniques * Solid analytical skills * SolidWorks experience
It is the policy of GCR to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. GCR is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population.
Job Status: Contract/Temporary