What are the responsibilities and job description for the Senior Manufacturing Engineer position at ACE Partners?
Senior Manufacturing Engineer - Medical Device Production Leader
This role involves leading and optimizing manufacturing processes for innovative single-use medical devices, driving efficiency, quality, and scalability in a dynamic company.
Key Responsibilities:
- Develop, implement, and refine manufacturing processes to enhance efficiency, quality, and cost-effectiveness.
- Lead process verification and validation to support commercial production launches.
- Address and resolve non-conformances through the NCR/CAPA system.
- Optimize workflow and facility layout for improved safety and productivity.
- Establish standardized work procedures and equipment operating parameters.
- Collaborate with product development teams on tooling, fixtures, and automation solutions.
- Troubleshoot equipment issues and implement process improvements.
- Drive cost reduction initiatives and minimize material waste.
- Work with Quality Control to resolve supplier-related quality concerns.
- Develop capital equipment proposals for process scaling and advancements.
- Ensure alignment of manufacturing objectives with validation, clinical trials, and product launch timelines.
- Delegate tasks effectively and track project performance.
- Manage resources and optimize allocation.
Qualifications:
- Bachelor's degree in manufacturing, Mechanical, Industrial, or Plastics Engineering.
- 8 years of experience in equipment-intensive manufacturing, preferably in an ISO 9000 environment.
- Proven project management skills with a record of driving successful outcomes.
- Proficiency in SolidWorks for fixture and tooling design preferred.
- Experience in plastics processing (extrusion, injection molding, fiber forming) is a plus.
- Familiarity with ISO 13485 standards is advantageous.
- Strong organizational and leadership skills.
- Excellent communication and adaptability in dynamic environments.
