5+ years of experience in medical device manufacturing
Hands-on mechanical aptitude with production equipment
Solid experience with lamination or laser welding
Experience editing Manufacturing Procedures, Lot History Records, and Bills of Materials
Ability to work independently in a fast-paced environment
Strong verbal and written communication skills
Responsibilities
Support the manufacturing line and advance processes for scale-up
Create and document new manufacturing processes for higher volumes
Quickly solve issues with production equipment to maintain workflow
Spend significant time on the manufacturing line to improve processes and quality
Monitor ongoing processes
Assist in developing assembly and test fixturing for quality and volume
Write protocols and test reports for validation activities
Generate quality documentation like NCRs and CAPAs
Collaborate with suppliers to enhance manufacturability and reduce costs
Qualify components from new suppliers for supply chain flexibility
Benefits
Hands-on role with direct involvement in manufacturing
Opportunity to work closely with a diverse team of assemblers
Engagement in innovative medical device production
Potential for professional growth in a small company environment
Focus on quality and regulatory adherence in manufacturing processes
Full Job Description
We are seeking a Manufacturing/Process Engineer to support the production and improvement of our innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability. This is a hands-on role requiring direct involvement with manufacturing equipment. Candidates with primarily theoretical or design-only backgrounds will not be a fit.
Roles and Responsibilities:
Primary focus: Support the manufacturing line and advance the processes/device to support scale up.
Create and document new manufacturing processes as necessary for production at significantly higher volumes and validate as appropriate
Support ongoing manufacturing activities including dealing with production equipment, non-conformances, facilities and other line related issues. This includes quickly SOLVING issues with laminators, laser welders, hot boxes, etc. in order to keep the line moving.
Spending significant time on the manufacturing line alongside the assemblers to improve processes and increase quality. You are the primary interface between engineering and production.
Responsible for ongoing process monitoring
Assist development of assembly and test fixturing with a focus on quality and volume
Write protocols & test reports related to validation activities
Generate/support Quality documentation to represent Manufacturing: NCR's, CAPA's, deviations, etc.
Collaborate with existing suppliers to improve manufacturability and decrease cost
Qualify components from new suppliers to improve supply chain flexibility
Skills, Experience, & Behaviors:
Demonstrated ability to collaborate effectively, especially with a team of diverse assemblers
Solid history of experience in a medical device manufacturing environment (5+ years preferred)
Hands-on mechanical aptitude with direct experience working on production equipment is required
Solid experience with either lamination or laser welding is required
Proficiency in SolidWorks is helpful but not required
Experience editing Manufacturing Procedures (MPs), Lot History Records (LHRs), Bills of Materials (BOMs), etc. is required
Comfort using inspection and test equipment (vision systems, tensile testing) is a plus
Experience working within and maintaining compliance in a highly regulated environment
Demonstrated ability to work independently in a fast-paced, small company environment
Flexibility and willingness to take on a variety of roles
