Oscor Inc. designs, manufactures, and markets a variety of highly specialized implantable cardiac pacing leads, venous access systems and diagnostic catheters. Oscor is proud to offer excellent career opportunities, great benefits and the ability to work as a team producing and delivering products which improve patients’ lives.
This position will be responsible for coordinating new product development according to customer specifications, developing hands-on product solutions and improving manufacturing methods, systems and processes to produce a high quality product at optimal cost. The Project Engineer manages a complete device project from the early development stage, through detailed manufacturing process development to technology transfer to production floor.
- Coordinates new product development with customers or according in-house requirements.
- Generates all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
- Conducts component and device testing.
- Accurately generates standard written reports.
- Develops plans to evaluate process repeatability and stability through equipment qualification and process validation.
- Ensures compliance with QSR and internal protocol. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
- Designs, develops, and implements basic manufacturing fixturing and tooling.
- Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment.
- Provides support in the resolution of product complaints and/or safety issues.
- Works with various departments to facilitate pilot production of new products.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/QSR regulations.
- Transfer as required engineering project from engineering into manufacturing.
- B.S. or Master Degree in related Engineering discipline (Biomedical or Mechanical preferred) or equivalent technical degree backed with work experience in related field
- 0-2 years of experience in medical devices
- Familiarity with FDA, QSR and ISO regulated environment
- Background in injection molding, extrusion or catheter development is a plus
- Some domestic and international travel might be required
Oscor has a rewarding benefits program with a generous amount of PTO as well as paid holidays, medical, dental, and vision insurance, company paid short term and long term disability, as well as 401K partial match
Oscor Inc. is an Equal Opportunity Employer and a Drug Free Workplace