Product Development Engineer

Development or Process Engineer

3D Systems Healthcare is in search of a skilled Biomedical or Mechanical Engineer to support the development and production efforts in a partnership with the U.S. Department of Veterans Affairs (VA) for the development of medical devices using additive manufacturing

The job-site for this position is at the VA Medical Center in Pittsburgh, PA. Unfortunately, there is no option for remote or hybrid work.

Essential Functions

The Process Engineer has the following responsibilities:

• Create project/process/product plans with input and direction from supervisors

• Execute project/process/product plans in an independent manner. This may include: background research into a problem topic, design with CAD, Matlab, or physics simulations; data analysis with tools such as Matlab, SPSS, or Excel; analysis of regulatory pathways; and physical experiments. Responsibilities may include whole projects/process/product with assistance from others or assisting other on a portion of a project/process/product.

• Assisting with procurement in support or project/process/product as appropriate. Either directly or in cooperation with technicians and machinist, produce physical parts, assemble devices, or package items, in support of projects/processes/products.

• Properly document salient aspects of the project/process/product in accordance with the quality system.

• Communicating status of work, in meetings, email, presentations, or other documents in a clear, concise, and timely manner.

• Maintain a clean and organized workspace, ensuring compliance with safety regulations.

• Comply with site-specific workflow, training, and procedures.

• Comply with all relevant VA training and regulatory reporting.

• Contribute to the VA's mission of serving our nation's Veterans.

Qualifications - External

Education and Training

• Bachelor's degree (B.S.) in engineering and a minimum of 2 years of experience supporting controlled/regulated manufacturing operations as a process engineer.

• Preferred experience in the medical device industry under FDA/ISO 13485 design controls.

• Knowledge, Skills, Abilities

• Able to work independently driving project as a part of cross-functional teams.

• Working knowledge of cGMP, FDA CRF 820, ISO 13485, and ISO14971.

• Strong analytical and decision-making skills.

• Experience with quality tools and process improvement techniques.

• Solid understanding and background in core manufacturing engineering fundamentals, such as process development, design work, stress/strain, data analysis, statistics, testing/inspection, supplier interaction, structured problem solving tools, change control, and process validation.

• Broad practical knowledge and skill in using, computer-aided design (CAD), modeling software including mesh modeling and slicing software, 3D scanning and manipulating scans in CAD software.

• Broad practical knowledge and skill in using 3D printers of multiple fabrication processes, including not but limited to FDM, SLA, cDLM, PolyJet/Multi-Fusion and SLS. Must be capable of selecting the appropriate fabrication process for the task assigned.

• Thorough understanding of material properties and which material applies to the fabrication process being utilized. Incumbent must be able to select the appropriate material to use for the application of the device being produced.

• Understanding of different failure modes and how they are applicable to different processes, different applications and different geometries thus knowing the weaknesses amongst the fabrication process of choice.

Other

• Pass a Government background check and be eligible for a PIV CardTravel

• 5-10% Travel for collaboration, conferences, and training

• This position is based out of Pittsburgh, PA.

Why 3D Systems?

Make a meaningful difference!

Founded in 1986, we are the original pioneers of 3D printing. And today, we have a global team that is at the forefront of shaping the entire additive space that spans everything from aerospace to healthcare. What we're doing in digital manufacturing is changing lives and transforming how the world makes things. It's a big responsibility to have this type of impact. And it's where we thrive.

Be you, at your best!

We care about treating people right and we know that life is more than work. This is why we approach rewards and benefits at a personal level so that you have the resources you need to take care of yourself and be you, at your best.·

In addition to a salary, this position is eligible for an annual bonus based upon company performance.·

3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and 8 holidays per year are also provided as paid time off. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.

3D Systems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, ethnicity, religion, sex, age, sexual orientation, genetic information, marital status, gender identity or national origin or because he or she is an individual with a disability or a disable veteran, Armed Forces service medal veteran (referred to collectively as "protected veterans"). The Company also provides applicants with equal employment opportunities without regard to pregnancy, childbirth, medical needs arising from pregnancy or childbirth, and related medical conditions including, but not limited to, lactation.