Development Quality Engineer II at 3D Systems in Littleton, Colorado

Job Description:

Job Title: Development Quality Engineer II

Company Overview:

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.

Job Description:

Overview:

As an Intermediate Product Development Quality Engineer, you will play a pivotal role in the design, development, and quality assurance processes of cutting-edge medical devices. You will work closely with cross-functional teams to ensure compliance with industry regulations, meet customer expectations, and deliver high-quality products to the market.

Responsibilities:

• Collaborate closely with cross-functional product development teams to establish, implement, and maintain quality standards throughout the product development life cycle.

• Develop, execute, and oversee risk management activities, including risk assessments, hazard analyses, and risk mitigation strategies, in compliance with industry regulations and standards.

• Provide input and review and approve product and process validation activities.

• Lead and participate in design and process failure mode and effects analysis (DFMEA and PFMEA).

• Identify and development of test methods, inspection plans, and quality control procedures.

• Ensure compliance with applicable regulatory requirements, such as FDA, ISO, ITAR, and other relevant standards.

• Investigate and address product non-conformances, root cause analysis, and implement corrective and preventive actions (CAPA) where appropriate.

• Provide guidance and support to the design and engineering teams to address quality concerns and improve product design and manufacturability.

• Assist in supplier quality management and supplier audits to ensure the quality of incoming materials and components.

• Maintain accurate quality documentation, including design history files, risk management files, and test records.

• Collaborate with regulatory affairs and provide input for regulatory submissions.

• Continuously monitor industry trends and regulatory updates to stay current with best practices and compliance.Qualifications:

• Bachelor's degree in engineering, preferably in biomedical, mechanical, or a related field; or equivalent combination of education and experience.

• 3-5 years of experience in quality engineering, preferably in the medical device industry.

• Knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971).

• As this role includes development of parts covered under ITAR, candidate must be a US Person.

• Strong understanding of quality tools and methodologies, including FMEA, CAPA, and statistical analysis.

• Quality certifications (e.g., ASQ Certified Quality Engineer) desirable.

• Experience with product and process validation, design control, and risk management.

• Excellent problem-solving and analytical skills.

• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.

• Detail-oriented with a high level of accuracy in documentation.

• Ability to work independently and prioritize tasks in a fast-paced environment.

• Applied experience with and understanding of additive manufacturing a plus.

Benefits:

• Competitive salary and benefits package.

• Opportunities for professional growth and development.

• A collaborative and innovative work environment.

• Access to cutting-edge technology and resources.

• Contribution to the development of life-saving medical devices.

The Good Stuff!

• Salary Range: $75,000 - $100,000 (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. 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.