Confidential Posting
Job Summary
- Location
- Portland, OR 97224
- Industries
- Medical Devices and Supplies
- Job Type
- Full Time
- Employee
- Years of Experience
- 5+ to 7 Years
- Education Level
- Bachelor's Degree
- Career Level
- Experienced (Non-Manager)
- Salary
- 68,000.00 - 81,000.00 USD /year
- Job Reference Code
- prod dev
Mechanical Engineer--Medical Device
About the Job
Job Summary:
This position will report into the R&D organization to provide hands-on engineering design support and validation testing for all phases of medical device product development; from concept to launch and ongoing product improvement. Additional responsibilities include creating engineering drawings, designing test protocols, maintaining design history files, evaluating results, and compiling reports.
Essential Job Functions:
•Work in a multidisciplinary group developing novel materials that enhance medical device performance as well as new products within this growing industry segment.
•Assist in engineering design and maintenance of medical devices and components and assemblies.
•Develop test protocols, evaluate results, and compile reports to assure materials and components meet standards.
•Perform sampling, physical and biological testing of products and components in accordance with approved protocols and Standard Operating Procedures.
•Evaluate the performance and safety of prototype, test, and production builds.
•Participate in project team meetings and design reviews.
•Coordinate regularly with Business Development and Manufacturing groups.
•Collaborate with Quality Assurance in establishing procedures for insuring product consistency and quality.
•Maintain testing laboratory in accordance with GLP procedures.
Attributes:
Must posses the desire to work in a small entrepreneurial and matrix team environment; and possess the hands-on ability to quickly design and implement simple solutions to complex problems. Must also be dependable, able to produce timely results, and driven by the success of the organization.
Requirements/Experience:
•B.S. in Mechanical or Biomedical Engineering plus at least 3 years experience; or M.S. in Mechanical or Biomedical Engineering with at least 2 years experience.
•A strong working knowledge of GMP, FDA, ISO13485:2003, and MDD standards and requirements.
•Knowledge of manufacturing and process development activities such as qualification, FMEA and design for manufacturing is required.
•Experience with surgical devices highly desired.
•Experience with CAD software and the design and maintenance of engineering and QC fixtures a plus.
This position will report into the R&D organization to provide hands-on engineering design support and validation testing for all phases of medical device product development; from concept to launch and ongoing product improvement. Additional responsibilities include creating engineering drawings, designing test protocols, maintaining design history files, evaluating results, and compiling reports.
Essential Job Functions:
•Work in a multidisciplinary group developing novel materials that enhance medical device performance as well as new products within this growing industry segment.
•Assist in engineering design and maintenance of medical devices and components and assemblies.
•Develop test protocols, evaluate results, and compile reports to assure materials and components meet standards.
•Perform sampling, physical and biological testing of products and components in accordance with approved protocols and Standard Operating Procedures.
•Evaluate the performance and safety of prototype, test, and production builds.
•Participate in project team meetings and design reviews.
•Coordinate regularly with Business Development and Manufacturing groups.
•Collaborate with Quality Assurance in establishing procedures for insuring product consistency and quality.
•Maintain testing laboratory in accordance with GLP procedures.
Attributes:
Must posses the desire to work in a small entrepreneurial and matrix team environment; and possess the hands-on ability to quickly design and implement simple solutions to complex problems. Must also be dependable, able to produce timely results, and driven by the success of the organization.
Requirements/Experience:
•B.S. in Mechanical or Biomedical Engineering plus at least 3 years experience; or M.S. in Mechanical or Biomedical Engineering with at least 2 years experience.
•A strong working knowledge of GMP, FDA, ISO13485:2003, and MDD standards and requirements.
•Knowledge of manufacturing and process development activities such as qualification, FMEA and design for manufacturing is required.
•Experience with surgical devices highly desired.
•Experience with CAD software and the design and maintenance of engineering and QC fixtures a plus.
