Quality Design & Development Engineer (Medical Devices)

Picture your day starting on the manufacturing floor in Big Lake, MN, walking product lines with engineers and technicians, reviewing new verification data, and planning the next validation step. By mid-morning, you’re leading a risk review for a Product Development Process (PDP) milestone. In the afternoon, you’re partnering with suppliers on component qualifications and closing the loop on sampling plans. You report to the Quality Engineering Manager and serve as a key voice for Quality Design & Development (QD&D) across both new product initiatives and sustaining manufacturing and distribution.

• Create and execute Quality Plans for design and development projects, aligning deliverables to PDP gates.
• Initiate, maintain, and update Risk Management documentation with cross-functional engineering teams per project requirements.
• Define severity- and risk-based Process Master Validation Plan strategies with clear V&V rationales.
• Support operational and process qualifications for customer manufacturing processes in partnership with engineering.
• Develop test methods that balance operational and business needs; drive Test Method Validations to confirm effectiveness.
• Implement inspection strategies for incoming materials, in-process stages, and final product release.
• Build statistically sound sampling plans and characterize test and inspection methods.
• Represent Quality Engineering during design reviews to champion compliance and product quality.
• Support initial qualification audits for customers and regulatory agencies.
• Lead or support supplier and vendor qualification activities, including design characterization, audits, and assessments.
• Advance Quality Best Practices and continuous improvement in GDP/GMP.
• Apply structured problem-solving to identify, prioritize, communicate, and resolve quality issues.
• Ensure site personnel adhere to the site Quality Management System (QMS) and required training.
• Contribute to the development of Quality Agreements with external customers.
• Follow the TOMZ Quality Management System and perform other duties as assigned.

• Advanced post-secondary education, training, or certification coursework.
• Proficiency with statistical techniques to analyze process capability.
• Quality certifications preferred (e.g., ASQ CQE, QCI, etc.).
• Hands-on skill with First Article Inspections and Component Qualifications.
• Knowledge of external standards: ISO 900/9001, ISO 13485, 21CFR 820, and EU MDR, including product development and design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), CAPA, and complaint handling.
• Experience supporting customer and external regulatory audits effectively.
• Strong written and verbal English communication.
• Ability to meet TOMZ-specific positional and functional on-the-job training requirements.
• Proficiency with Microsoft Office.
• Self-starter who can work independently and collaboratively across R&D, Manufacturing, and QA.

• Bachelor’s degree (4-year) or equivalent directly transferrable industry experience; Engineering or Quality discipline preferred.

• 2–5 years in a regulated manufacturing environment.
• Background in Class I, II, and/or III medical device manufacturing within a regulated setting (e.g., Aerospace, Defense, Pharmaceutical, etc.).

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds (team lift or mechanical assistance required over 50 pounds).
• Ability to sit for extended periods.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE such as safety glasses, dust masks, ear plugs, and cut-resistant or chemical-resistant gloves, along with engineering controls, may be required.
• Frequent computer use and keyboard entry.

• GD&T
• Quality Inspection Experience
• Continuous Improvement
• Quality Control Experience
• Good Manufacturing Practices (GMP)
• Quality Control Data Analysis