The Quality Engineer II will support the PASCAL Gen 3 product line at our Draper facility, partnering closely with manufacturing, supplier quality, and cross-functional engineering teams to stabilize a new product line, improve yield, resolve quality issues, and help prepare for future product launches. Your work will help ensure commercially released and human-use products continue to meet rigorous quality expectations while directly impacting patients around the world. The Quality Engineer II will also be a part of next-generation process development.
You will make an impact by:- Supporting sustaining Quality Engineering activities for the PASCAL Gen 3 product line, including stabilization of a new product line, commercial part number support, and continuous improvement of manufacturing quality performance.
- Utilizing learnings from current generation sustaining to develop and launch the next generation PASCAL products
- Partnering with Manufacturing Engineering, Supplier Quality Engineering, Operations, and other cross-functional partners to identify quality trends, improve yield, and drive metrics-based improvements across the production line.
- Owning or supporting nonconformance activities, including NCR authoring, investigations, dispositions, containment, corrective actions, NCR reductions, and related documentation in accordance with quality system requirements.
- Developing, executing, reviewing, and approving engineering studies, test method validations, and manufacturing process validation deliverables, with emphasis on TMVs and OQ/PQ protocol and report review.
- Creating, optimizing, and sustaining dimensional inspection routines, including Keyence programming or similar optical/automated inspection methods used to support manufacturing and human-use product requirements.
- Applying engineering and quality tools such as root cause analysis, risk assessment, FMEAs, statistical methods, Lean/Six Sigma, and structured problem solving to improve process capability and reduce manufacturing risk.
- Providing technical feedback to supplier quality partners regarding supplier-related quality issues, inspection approaches, material performance, and opportunities to improve incoming or in-process quality.
- Developing, updating, and maintaining technical documentation, work instructions, validation documentation, risk documentation, and training materials to ensure effective production support and knowledge transfer.
- Collaborating with technicians, inspectors, engineers, and production teams by assigning support tasks, providing technical guidance, reviewing test work, and helping reinforce quality expectations on the manufacturing floor.
What you'll need (Required):- Bachelor's degree in engineering or scientific field with two (2) years of Quality Engineering or Manufacturing Engineering experience in a production, manufacturing, or operations environment; OR Master's degree in engineering or scientific field with no experience (or applicable internship/co-op experience).
- Experience supporting production line sustaining activities.
- Experience working in a highly regulated industry such as medical device, aerospace, automotive, semiconductor, or a similarly regulated manufacturing environment.
What else we look for (Preferred):- Medical device industry experience.
- Hands-on NCR authoring experience, including investigation, disposition, root cause analysis, corrective action, and documentation closure.
- Keyence programming experience or experience creating/sustaining optical dimensional inspection routines using similar automated inspection technology.
- Experience with process validations and test method validations, including protocol execution, report writing, and review of Test Method Validation and OQ/PQ documentation.
- Experience with FMEAs, risk management documentation, root cause analysis, CAPA support, investigations, and quality improvement initiatives.
- Working knowledge of quality systems, manufacturing documentation, engineering change control, investigations, and compliance expectations.
- Ability to use data, metrics, and statistical techniques to identify trends, improve yield, reduce defects, and support manufacturing decision-making.
- Strong documentation, communication, and interpersonal skills with the ability to partner effectively across cross-functional teams.
- Strong problem-solving, organizational, analytical, and critical thinking skills with strict attention to detail.
- Ability to manage competing priorities in a fast-paced production environment.
