Product Development Engineer I

Scanlan International; Saint Paul (MN); On-site; USD 68,000 - 109,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Group Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

401(k) Plan with Company Match

Paid Time Off

Job summary

Scanlan International, Inc. in St. Paul, MN is seeking a Product Development Engineer I to join our team responsible for design, testing, and lifecycle support of Class I and II medical devices.

This on-site role reports to the Director of Research and Development and involves cross-functional collaboration with engineers, suppliers, and customers. Responsibilities span design controls, verification, validation, and lifecycle activities.

Qualifications

• Bachelor of Science in Engineering from an accredited institution.
• 0 to 2 years engineering experience applying engineering fundamentals in product development, testing, manufacturing, quality, or a related technical environment.
• 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.

Responsibilities

• Design-controls, requirements and compliance activities; maintain and trace requirements.
• Prepare test plans, protocols, and reports; conduct testing and document deviations.
• Support lifecycle activities and cross-functional collaborations for new-product and improvement concepts.
• Participate in risk management, design reviews, and change-control activities.

Skills

Communication

Analytical thinking

Documentation

Cross-functional

Education

Bachelor of Science in Engineering

Tools

Jama Connect

Design-History Documentation

Data Acquisition Systems

Lab Test Equipment

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

R & D Regular Full-Time Professional Scanlan International, Inc., St. Paul, MN, US

Salary Range: $68,200.00 To $109,100.00 Annually

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Product Development Engineer I to join our organization and continue this commitment.

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 elevate 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 elevate 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.

• 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)
• Training and Development Program
• Tuition Assistance Program
• Paid Time Off, including holidays, floating holidays, vacation, and earned sick and safe time (ESST)

Applicants with disabilities who need accommodation to complete the Scanlan International, Inc. application process should contact Human Resources at 1.800.328.9458 or email [e-mail] .

Scanlan International is an EEO employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please click the following link to view Federal and E-Verify posters: https://www.e-verify.gov/employees