Your opportunity to develop structure and ensure safety in new product development!
If you have excellent attention to detail, engineering skills, and a desire to work collaboratively in a team environment on varied projects, then you will be successful at Oakworks. This is your opportunity to advance a career that will include both medical devices and commercial products in order to bring innovative solutions to improve the clinician’s work environment and the patient’s treatment experience. You will be a key member of the research and development team as you lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/ Validation for new and existing products. As Oakworks R&D department is located at the same facility as production, this enables working hands-on with the products and will require the employee to work on-site. As the Design Assurance Engineer, you will ensure compliance to US and EU Medical Device Design Regulations such as EU MDR, ISO13485 and FDA QSR’s, while being responsible for the creation and maintenance of the Design History File, Technical File, and DMR for new and legacy products. During periods between product development, this role will support the R&D department through project management, engineering, drafting, or work on special projects.
Must have BA or BS degree in engineering, physical sciences, or closely related field. 3 or more years of related experience in medical product development or other regulated industry experience is preferred. This experience might include time in a role such as a Quality Engineer, Development Engineer, Regulatory and Compliance Engineer, or Design Engineer. Requires a strong understanding of industry regulations such as ISO13485 and FDA QSR’s. Strong proficiency in Microsoft Word required. Experience with Autocad Inventor preferred, but not required. The ideal candidate will possess strong computer skills, verbal and written communication skills, organizational skills, project management, and time management skills.
Hours and Status:
The normal schedule is Monday through Friday with core hours from 9:00am to 3:00pm and flexibility on start and end times. This is a full time, benefits eligible position.
Oakworks brings high quality, innovative products to the health and wellness market. As a leading manufacturer of medical, spa, and massage tables we’re proud to support customer and employee wellness. Since its beginning in 1978, Oakworks has maintained a commitment toward environmental conservation and is conveniently located in New Freedom, PA between York, PA and Baltimore, MD. We invite you to join our team!
Equal Opportunity Employer
Oakworks does not provide sponsorship or relocation assistance.
To apply submit a resume and cover letter to:
Email: through Indeed
Mail: 923 E. Wellspring Road, New Freedom, PA 17349-8408
Equal Opportunity Employer
Job Type: Full-time
- EU MDR: 1 year (Preferred)
- ISO13485 and FDA QSR’s: 1 year (Preferred)
- Engineering: 3 years (Preferred)
- Medical Device manufacturing environment: 3 years (Preferred)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Flexible schedule
- Tuition reimbursement