3D Systems Healthcare Solutions is a leading player in the medical device industry, dedicated to improving healthcare through innovation and cutting-edge technology. We are seeking a qualified Intermediate Quality Engineer to join our New Product Development (NPD) team to ensure the quality and safety of our products.
What We Are Looking For
We are seeking a highly skilled and motivated Senior Product Development Engineer to join our dynamic team in the design and development of cutting-edge medical devices. The Product Development Team in Littleton, Colorado is focused on patient-matched devices, manufactured via 3D printing platforms. The ideal candidate will have deep expertise in product design, engineering principles, and medical device regulations, with a passion for developing innovative solutions to improve patient care.
As a Senior Product Development Engineer, you will play a key role in the development of new products from concept through commercialization. You will collaborate with cross-functional teams, including Business Development, Quality, Regulatory, and Manufacturing, to ensure products meet safety, performance, and regulatory requirements. As a customer facing role, you will be interacting directly with surgeon design teams and medical device OEMs. You will be responsible for driving and managing product development timelines, technical risks, and ensuring product quality and compliance.
What You Will Do
Product Development: Lead the design and development of medical devices from concept through to market launch, ensuring product quality, manufacturability, and adherence to timelines and budget.
Design & Prototyping: Gather design inputs, create detailed design specifications, models, and prototypes from a variety of 3D printers and materials (both metal alloys and polymers). Conduct design iterations based on feedback and testing.
Cross-Functional Collaboration: Work closely with cross-disciplinary teams including Regulatory, Quality, and Manufacturing to ensure seamless development and adherence to medical device standards (e.g., ISO 13485, FDA QSR).
Technical Leadership: Provide technical guidance and mentorship to junior engineers, fostering a collaborative and innovative development environment.
Compliance & Regulations: Ensure compliance with relevant medical device regulations and support regulatory filings.
Risk Management: Collaborate on risk management activities (e.g., FMEAs, hazard analysis) to identify and mitigate potential design, safety, and performance risks.
Design Verification & Validation: Plan and execute design verification and validation activities to ensure the device meets all required specifications and regulatory standards.
Documentation: Maintain thorough and accurate design history files, engineering documentation, and regulatory submissions. Develop device master records, workflows, work instructions, travelers, and product labeling.
Continuous Improvement: Participate in continuous improvement initiatives by identifying opportunities for process, design, or efficiency enhancements.
What You Will Bring
Education
Bachelor's degree in Mechanical, Biomedical, or related engineering discipline required.
Master's degree in Mechanical, Biomedical, or related engineering discipline preferred.
Experience
4-6 years of experience in product development, with a proven track record in the medical device industry.
Experience with the full product development lifecycle, including concept development, prototyping, testing, regulatory approval, and commercialization.
Deep knowledge of medical device design controls and quality management systems (ISO 13485, FDA 21 CFR Part 820). For example, history of contributing to 510(k) or other regulatory submissions.
Technical Skills
Strong knowledge of engineering principles, statistics, materials science, mechanical design, and human anatomy with respect to musculoskeletal structures.
Proficiency with CAD software (e.g., SolidWorks). Working knowledge of Geomagic Freeform and Materialise 3-Matic preferred.
Experience with medical device testing, including cadaveric, mechanical, and biocompatibility testing.
Familiarity with design for additive manufacturing, digital workflows, SLS, SLA, and/or DMP highly preferred.
Experience creating patient-matched medical devices preferred.
Working knowledge of orthopedic surgical techniques and tools preferred.
Project management experience is highly preferred.
Soft Skills
Strong problem-solving abilities and technical troubleshooting skills.
Excellent communication skills, with the ability to effectively communicate complex technical concepts to both technical and non-technical stakeholders. For example, experience with communicating and conveying information to/from surgeon design teams and demonstrated ability in understanding user needs and design requirements.
Ability to work in a fast-paced environment and manage multiple projects simultaneously.
The 3D Systems Advantage!
Salary Range: $90,000 - $105,000 annually (Salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data)
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. Flex (Vacation) Time, Sick Leave, FAMLI Leave, Parental Leave, and 9 holidays per year are provided as paid time off. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match. Educational assistance and supplemental health and life plans are available.
Applications will be accepted online through December 13th, 2024.
