Senior, Product Development Engineer - 240000HD - 3D Systems

Who We Are
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
compli
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
musc loskeletal 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