Job Description

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.
Reporting:

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.