Product Development Engineer I

The Product Development Engineer I contributes to the design, testing, and lifecycle support of Class I and Class II medical devices, including reusable surgical instruments and single-use products. Working with experienced engineers and cross-functional partners, this engineer completes defined assignments, documents results, follows established development and quality processes, and builds increasing independence through training and experience. This position is located at our headquarters office, south of downtown St. Paul. We welcome an on-site work environment from Monday to Friday. This position reports to the Director of Research and Development. What You'll Do As a Product Development Engineer I: 30% -- Design Controls, Requirements, and Compliance • Complete assigned product-development and lifecycle activities using established procedures; track commitments and raise questions, risks, or delays to the project lead. • Prepare and update assigned product-development records using approved templates; check documentation for completeness and consistency and incorporate reviewer feedback. • Enter and maintain assigned requirements and traceability using Scanlan's requirements-management tools and processes. • Prepare assigned requirements and design-control records for formal design reviews, complete assigned actions, and raise evidence gaps or approval concerns to the project lead. • Draft and revise procedures, specifications, test methods, protocols, reports, and change assessments using approved templates and incorporate reviewer feedback. 30% -- Verification, Validation, and Product Testing • With guidance, prepare test plans, protocols, acceptance criteria, and reports; conduct approved testing, analyze results, document evidence, and report deviations. • Support external testing and validation with laboratories, suppliers, design partners, and subject-matter experts; organize required information, review results with the project team, and document deviations or evidence gaps. 25% -- Product Concept and Lifecycle Support • Support new-product and product-improvement concepts by gathering stakeholder needs, completing assigned feasibility work, and summarizing findings for the project team. • Support assigned design-transfer and product-lifecycle activities with cross-functional teams, customers, suppliers, and external resources; complete readiness tasks and document implementation of approved decisions. • Participate in Design-to-Cost and Design-for-Manufacturability reviews and update assigned requirements, risk records, verification plans, and design-control documentation to reflect approved decisions. • Help define product and process characteristics that affect quality and ensure approved requirements are reflected in applicable specifications and inspection records. 15% -- Risk Management, Design Reviews, and Change Control • Support risk-management activities by identifying potential hazards, documenting risks and controls, and helping confirm that risk controls are effective. • Participate in formal design reviews and change-control activities, complete assigned actions, assess defined design-control impacts, and escalate significant or unclear issues. Required Qualifications: Education: • Bachelor of Science in Engineering from an accredited institution. Experience: • 0 to 2 years of engineering experience applying engineering fundamentals in product development, testing, manufacturing, quality, or a related technical environment. Medical-device or regulated-industry experience is not required. • Ability to apply engineering principles to defined technical assignments and communicate conclusions based on available evidence. • Ability to prepare and interpret clear technical documentation and communicate results to technical and nontechnical partners. • Demonstrated ability to organize information, analyze technical issues, draw evidence-based conclusions, and seek guidance when an issue exceeds assigned authority or experience. Skills • Ability to communicate clearly, collaborate across functions, respond to feedback, and seek guidance when needed. • Analytical and problem-solving skills to evaluate defined technical issues, organize evidence, identify gaps, and develop recommendations with guidance. • Ability to review technical documentation, requirements traceability, risk records, and verification or validation evidence; incorporate feedback; and escalate issues beyond assigned authority. • Ability to work effectively with cross-functional teams, suppliers, and external partners and to seek guidance when priorities or technical positions differ. Preferred Qualifications: • Experience in medical devices, healthcare technology, or another regulated industry is preferred. Familiarity with quality systems, risk management, or regulatory requirements is beneficial. • Experience with one or more structured product-development activities, such as requirements, design reviews, product testing, risk management, design transfer, or change control. • Experience using statistical, experimental, or root-cause analysis methods to evaluate engineering data and solve technical problems. • Familiarity with specialized tools or records used in product development-such as Jama Connect, formal design-history documentation, data-acquisition systems, or laboratory test equipment-is helpful but not required. • Organization, time management, and the ability to complete assigned work through cross-functional collaboration. • Initiative, learning agility, coachability, sound judgment, and willingness to share knowledge with teammates. U.S. Work Authorization & Sponsorship Scanlan International will not offer or assume sponsorship of an employment visa for this position. Compensation We are committed to equitable and transparent pay practices. The salary range for this position is $68,200 - 109,100, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications. Comprehensive Benefits Offerings - Medical, Dental, and Vision Insurance - Group Life Insurance - Short-Term Disability Insurance - Long-Term Disability Insurance - 401(k) Plan with Company Match - Workers' Compensation - Employee Assistance Program (EAP) - Regular Part-Time Benefit Eligibility - Training and Development Program - Tuition Assistance Program - Paid Time Off, including holidays, floating holidays, vacation, and earned sick and safe time (ESST) How to Apply? Scanlan International, Inc. accepts online applications at https://www.scanlaninternational.com/contact-us/careers/