Development Quality Engineer II
Littleton, Colorado
Employer: 3D Systems Corporation
Industry:
Salary: $77000 - $95000 per year
Job type: Full-Time
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.
What We Are Looking For:
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.
What You Will Do:
Qualifications
What You Will Bring:
Benefits:
The Good Stuff!
Applications accepted online through October 21st, 2024.
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.
What We Are Looking For:
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.
What You Will Do:
- 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
What You Will Bring:
- Bachelor's degree in engineering, preferably in biomedical, mechanical, or a related field; or equivalent combination of education and experience.
- Established experience in quality engineering, with a strong background preferably in the medical device industry or a role encompassing significant quality engineering responsibilities.
- Knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971) strongly preferred.
- Strong understanding of quality tools and methodologies, including FMEA, CAPA, and statistical analysis strongly preferred.
- 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: $77,000 - $95,000 (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. 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 accepted online through October 21st, 2024.
Created: 2024-10-15
Reference: 240000G7
Country: United States
State: Colorado
City: Littleton
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