Statistics Validator Jobs in Minnesota (NOW HIRING)

Job Title: Product Development Engineer

Job Description

The Product Development Engineer designs and develops medical devices from initial concept through market release, with a focus on catheter-based technologies. This role combines hands-on mechanical design, process development, and validation activities to ensure products function as intended and meet regulatory requirements. The engineer maintains detailed documentation, performs risk analyses, and collaborates closely with cross-functional teams and external partners in a fast-paced, growing contract manufacturing environment.

Responsibilities

• Develop new product concepts and drive them from initial design through market release with limited support.
• Design and implement new methodologies, materials, machines, processes, or products to bring concepts to market.
• Create and maintain essential product and process documentation throughout all phases of product development.
• Contribute with minimal oversight to the execution of protocols and reports to support validation activities, including Design Verification.
• Conduct product and process characterization with minimal oversight to confirm that devices function as intended.
• Perform risk analysis for products under development and incorporate risk mitigation strategies into designs and processes.
• Coordinate activities with outside suppliers and consultants to ensure timely delivery of supplies and services needed to meet project timelines.
• Lead or support rapid design iterations and make informed design recommendations based on testing, feedback, and evolving project requirements.
• Independently develop and adapt work plans in response to vague or changing project goals, ensuring progress toward key milestones.
• Use SolidWorks 3D CAD to design components and assemblies for catheter-based and related medical device technologies.
• Support Design Verification and Design Validation activities in alignment with design control procedures and applicable regulations.
• Document development work clearly and thoroughly, including technical reports, test plans, test results, and design history records.
• Interact with clients and partner companies in a professional manner, providing technical updates and incorporating feedback into designs.
• Collaborate with R&D, engineering, and manufacturing teams to transition designs into robust, scalable processes.
• Apply knowledge of probability and statistics, and where applicable, use statistical tools such as Minitab to analyze data and support decision-making.

Essential Skills

• Bachelor's degree in Mechanical or Biomedical Engineering is desired; in lieu of a degree, relevant experience in a similar or equivalent role will be considered.
• 0–3 years of medical device design and development experience.
• Experience with Design Verification, Design Validation, and design control processes.
• SolidWorks 3D CAD proficiency, with the ability to design components and assemblies for mechanical and catheter-based devices.
• Knowledge of human cardiac and cardiovascular anatomy and physiology.
• Experience with catheter development, including C0/C1 catheter design.
• Hands-on approach to mechanical engineering, product development, and process development activities.
• Ability to lead rapid design iteration and make clear, data-driven design recommendations.
• Ability to independently develop and adapt work plans based on vague or changing project goals.
• Familiarity with FDA Quality System Regulation (QSR) and ISO medical device regulations.
• Knowledge of catheter-based technologies, including reinforced shafts, delivery systems, and steerable catheters (preferred).
• Knowledge of probability and statistics, with familiarity in statistical software such as Minitab (preferred).
• Depth of knowledge in one or more technical areas, such as finite element analysis.
• Comfort with technical writing, including preparation of protocols, reports, and other formal documentation.
• Customer-focused mindset with excellent written and oral communication skills.
• Ability to interact professionally with clients and external partners.
• Organized, motivated, and strong sense of ownership over work and deliverables.

Additional Skills & Qualifications

• Experience in new product development within medical devices, particularly in R&D and mechanical engineering environments.
• Experience working in a contract manufacturing or similar fast-paced, project-based setting.
• Familiarity with reinforced shaft design, delivery systems, and steerable catheter technologies.
• Experience using statistical analysis tools such as Minitab to support validation and characterization activities.
• Previous experience or interest in finite element analysis or other advanced technical disciplines.
• Demonstrated ability to bring products from concept to market, including participation in all key development phases.
• Strong organizational skills, with the ability to manage multiple tasks and timelines simultaneously.
• Motivated, proactive, and comfortable taking initiative in a collaborative environment.
• Comfortable working hands-on with prototypes, test setups, and process development equipment.

Work Environment

This role is based on-site in a collaborative, R&D-focused environment within a growing contract manufacturing organization. The culture emphasizes a balance of fun and hard work, encouraging hands-on involvement with products, processes, and equipment. You will work closely with cross-functional engineering and manufacturing teams, as well as external suppliers and consultants, to support rapid development cycles and on-time delivery of projects. The setting supports frequent interaction, open communication, and teamwork as you move products from concept through validation and into production.

This is a Permanent position based out of Minneapolis, MN.

The pay range for this position is $75000.00 - $125000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

The following benefits are available to full-time employees:• Flexible Time Off• 9 paid company holidays• Health, Dental, & Vision coverage• Short- & Long-Term Disability opt-in• Health Savings Account (HSA) & employer contribution• 401(k) & employer contribution• Parental Leave

This is a fully onsite position in Minneapolis,MN.

This position is anticipated to close on Sep 18, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.