Key Responsibilities
Process Development for New Products
- Lead the identification/development/qualification of new processes, fixturing/tooling, and technologies related to new product introductions into manufacturing.
- Lead in the development of test and inspection plans to ensure risk mitigation and quality requirements are met.
- Lead in the development of required documentation for process/test validation and test/inspection instructions.
- Collectively work with Product Development teams to ensure quality requirements and project schedules are met.
- Develop and implement manufacturing processes for new products in preparation of commercial production.
- Determine manufacturing equipment requirements.
- Oversee and assist in developing new or revised production procedures.
- Work with other Product Development engineers to ensure that products are optimally designed for manufacturing.
- Assist in the development of manufacturing TCOGS for new product introductions and provide ROI analysis for capital investments.
- Identify and implement alternative process methods that accelerate product development team’s ability in assessing new product design ideas.
- Develop and manage Process FMEA Support Product Launches and On-going Operations
- Assist in developing new or revised production processes.
- Provide technical support in troubleshooting and resolving manufacturing issues.
- Review requested process changes to ongoing manufacturing processes.
Documentation
- Create original manufacturing procedures.
- Work with engineers, designers, QA and Managers to develop and document manufacturing processes and other relevant procedures.
- Author process qualification documentation such as TMV, IQ, OQ and PQ.
- Create and maintain development records for design history files.
- Perform other duties as assigned.
Supervisory Responsibility
- Assign work to technicians, less experienced engineersand temporary employees as needed.
- Mentor less-experienced process development engineers and technicians
- Oversee and assist in the selection of outside vendors and consultants as required.
- Provide leadership and direction on project teams as it relates to the process development engineering functions.
- Provide leadership and direction for process and business improvements.
Level of Activity
Level of Supervision
- Associate Engineer Support: Is a mentoree and a higher level Process Development Engineer will provide direction and review their work prior to submitting deliverables
- Engineer I Support: Is a mentoree and a higher level Process Development Engineer will provide direction and review their work prior to submitting deliverables
- Engineer II Support/Lead: May be a mentoree or a mentor, some activities may be performed without supervision where demonstrated capability is shown. Supervision may be required for larger more complex deliverables.
- Senior Engineer Lead: Is a mentor, most activities are performed without supervision. May have direct report(s)
- Principal Engineer Lead:/Consult Is a mentor, all activities are performed without supervision. May have direct report(s)
- Engineering Fellow Consult: Is a mentor, all activities are performed without supervision. May have direct report(s)
Support
Provide support of an output or activity to a higher level
- Process Development Engineer – Lead: lead an output or activity. Support less experienced
- Process Development Engineers and Technicians – Consult: provide guidance to less experienced Engineers.
Requirements
Job Experience and Education
- BSME (or related disciple) and experience, preferably in the medical device field. Relevant experience in lieu of a degree shall be considered on a case-by-case basis.
- Ability to identify, evaluate and select appropriate process technologies and equipment to manufacture medical devices.
- Ability to quickly create and iterate process concepts.
- Ability to articulate tooling and equipment design requirements.
- Strong technical writing ability.
- Manufacturing process knowledge of various polymer and metal materials; specifically in catheter assembly, laser welding and packaging.
- Knowledge of tooling and process to produce component parts. • Understanding of various manufacturing and production monitoring techniques.
- Understanding of lean manufacturing.
- Ability to use analytical techniques such as DOE and SPC.
- Specialty knowledge may be required in specific instances.
Job Experience
Level of Experience
- Associate Engineer: 0-2 years; None to very little industry experience
- Engineer I: 1-5 years; Equivalent job experience
- Engineer II: 6-10 years; Medical device job experience
- Senior Engineer: 11-15 years; Experienced in all job requirements within the medical device industry
- Principal Engineer: 15-20 years; Experienced in a variety of disciplines within the medical device industry with broad product and clinical knowledge.
- Engineering Fellow: 20+ years; Experienced in a variety of technical disciplines within the medical device industry with broad product and clinical knowledge.
Physical Demands
- Must perform light lifting
- Working in a controlled environment fully gowned
- Ability to work extended hours as required
- Ability to travel
- Ability to work around RF and magnetic fields