Job Summary
The Process development engineer will support process development, validation, and standardization activities for a highly automated medical device manufacturing facility. This role will work cross-functionally to identify process gaps, support supplier qualification and audits, and ensure manufacturing processes meet applicable quality and regulatory requirements.
Pay
$110,000 per year
Shift
first
Duties
- Manage and support process development and process validation activities
- Identify gaps in existing manufacturing processes and implement improvements and standardization
- Standardize manufacturing processes across the Benbrook facility and external CMO partners
- Support facility coordination related to manufacturing and process-development activities
- Support supplier qualification activities
- Participate in and support supplier and manufacturing audits
- Drive validation, cleaning, and manufacturing compliance initiatives
- Partner with quality, supply chain, manufacturing, engineering, and other cross-functional teams
- Support process improvements associated with new product introduction
- Help establish consistent manufacturing practices across internal and external production environments
- Ensure processes are developed and maintained in accordance with applicable FDA and ISO requirements
Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering, materials engineering, or a related engineering discipline
- 3-5 years of experience in product development, process development, or a closely related engineering function
- Strong working knowledge of FDA 21 CFR requirements
- Strong knowledge of ISO 13485
- Experience with process validation in a regulated environment
- Proficiency with CAD software
- Proficiency with Microsoft Office Suite
- Ability to work cross-functionally with manufacturing, quality, supply chain, and engineering teams
- Six Sigma Green Belt or Black Belt experience or certification
- Experience supporting new product introduction
- Medical device manufacturing experience
- Experience working within highly automated manufacturing environments
- Experience supporting external contract manufacturing organizations
- Experience with supplier qualification and supplier audits
- Experience implementing and standardizing manufacturing processes across multiple sites or partners
Job Type
Direct Hire
