Summary of Functions:
Working Engineering and Operations to support transfer of newly developed products into manufacturing, industrialization of production lines, development of manufacturing processes and scale-up activities to support the Manufacturing team:
- Working closely with the R&D Engineers, support the Design Transfer activities for products entering production.
- Lead process improvement activities on existing production lines and support redesign activities to enable optimal manufacturability and performance.
- Provides support to the manufacturing teams enabling high yield production through process development, statistical process control, lean-six sigma activities, instilling a culture of Continuous Improvement and Operational Excellence.
- Development and maintenance of Inspection Guide Sheets for production, development and optimization of process flow diagrams, pFMEAs, optimization of production records and support of Manufacturing systems and Equipment.
- Provide training and guidance regarding manufacturing processes to operators.
Participates in all aspects of design and development of new products and changes to existing products including, but not limited to:
- Generating related design documentation;
- Assisting with, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ) as necessary;
- Performing product testing;
- Assisting with document control as necessary.
This position reports to the President Sports Medicine.
Major Duties and Responsibilities/Authority:
- Development of manufacturing processes in order to optimize output while minimizing cost;
- Generate work instructions for manufacturing processes;
- Provide guidance and training of machine programming and set-up to various members of Operations;
- Monitor and analyze process control and variation. Using statistical techniques, lean/six-sigma, kaizens, and Total Quality Management determine when changes are necessary to improve quality and lead the implementation of process improvements;
- Generate, review, and monitor control and validation activities;
- Ensure safety and quality considerations and requirements are pro-actively addressed and implemented in product production processes;
- Generating, reviewing, and/or approving product documentation including, but not limited to, design documentation (e.g. design plan, design inputs, etc.), drawings/prints, inspection procedures, protocols, reports, labeling, risk management documentation (e.g. risk management plan, risk analysis, etc.), deviation requests, and assist with regulatory submissions;
- Assist with maintaining Design History File (DHF), Risk Management File, Device Master Record (DMR), and Technical File as necessary;
- Assistance with design related issues (e.g. nonconformances, customer complaints, etc.);
- Project management and training as necessary;
- Assist in the timely resolution of safety and quality issues raised by customers or staff;
- Support Parcus Medical Quality System and Safety and Health Program by following procedures and advising others.
- Physical Requirements:
- Ability to work at a desk;
- The employee might be frequently required to climb stairs, kneel, or crouch, in accordance with job duties;
- Ability to lift up to 30lbs.
- Experience and/or Educational Requirements:
- Engineering degree, preferably Mechanical;
- 3+ years minimum industrial experience in a Medical Device industry supporting Operations teams as a Manufacturing Engineer; 5+ years experience with machining or molding operations preferred.
- Strong manufacturing experience with various CNC equipment;
- Track record of industrializing medical devices at production volume levels of 50-,1,000 units per batch, molding, machining, screw-machining, sand blasting, deburring experience preferred
- Experience with or ability to learn Statistical Analysis Methodology such as Six Sigma or LEAN;
- Experience with or ability to learn MS Office, SolidWorks and/or other CAD/CAM packages, and inspection/testing software;
- Medical experience and/or familiarity with FDA QSR’s and ISO 13485 desirable.