Development Engineer

Job Title: Development Engineer

Job Description

The Development Engineer plays a key support role in the design, development, and commercialization of new medical device products, as well as the maintenance of innovative products already in the market. This position focuses on translating clinical and user needs into safe, effective, and manufacturable orthopedic technologies that advance musculoskeletal healthcare and support market leadership in a highly regulated environment.

Responsibilities

• Stay current with and understand relevant arthroplasty product intended use, associated clinical procedures, and applicable regulations and standards.
• Engage with product users, often orthopedic surgeons, and observe similar device usage to identify and document user needs and unmet market requirements.
• Translate targeted user needs into clear design requirements and inputs that satisfy market needs, support business goals, and comply with global regulatory requirements and recognized industry standards.
• Create product designs that fully address user needs and design requirements, and author detailed design rationale to document the basis for all design features.
• Prepare and review information for invention disclosures and patent applications to protect intellectual property arising from new product designs.
• Initiate, instruct, and coordinate with cross-functional team members in the production and inspection of product prototypes for preliminary evaluation, design verification, design validation, and process validation.
• Develop product production specifications that appropriately account for design for manufacturability, process capability, and inspection requirements.
• Identify and document critical-to-quality product features based on intended use, design requirements, user risks, and the design itself to ensure appropriate quality control inspection plans are generated.
• Evaluate, verify, and validate product designs against design requirements and user risk reduction goals, in compliance with internal procedures and global regulatory requirements, including tolerance stack-ups, benchtop testing, and simulated operating room cadaveric product evaluations.
• Author, present, and obtain cross-functional approval of design control and risk management documentation as part of the product development process, ensuring alignment with internal procedures and regulatory expectations.
• Collaborate with sourcing and manufacturing teams to support new product design transfer activities for production of market-release quantities, ensuring smooth transition from development to manufacturing.

Essential Skills

• Experience in medical device product development within an FDA-monitored facility.
• Demonstrated understanding of medical devices and their clinical use, particularly in arthroplasty and orthopedic applications.
• Proficiency in 3D design tools and methods for mechanical and biomedical product development.
• Ability to translate user needs and clinical requirements into clear, testable design inputs and specifications.
• Knowledge of global regulatory requirements and recognized external industry standards relevant to medical devices.
• Experience with design verification, design validation, and process validation activities in a regulated environment.
• Ability to perform tolerance stack-ups and support benchtop and simulated clinical testing for product evaluation.
• Strong documentation skills for authoring design rationale, design control records, and risk management documentation.
• Ability to collaborate effectively with engineering, sourcing, and manufacturing teams during design transfer.
• Minimum of a B.S. degree from an ABET-accredited school (or global equivalent) in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering, or Aeronautical Engineering.

Additional Skills & Qualifications

• Prior development experience in an FDA-monitored facility, with a strong preference for medical technology environments; experience in pharmaceutical or aerospace industries is also valued.
• Familiarity with new product development processes in highly regulated industries.
• Understanding of design for manufacturability and process capability in a production environment.
• Experience contributing to invention disclosures and patent-related documentation.
• Comfort working closely with clinical stakeholders, such as orthopedic surgeons, to gather user insights.
• Strong analytical and problem-solving skills for assessing user risks and defining critical-to-quality features.
• Effective communication skills for presenting design concepts and obtaining cross-functional alignment.
• Commitment to innovation, quality, and continuous improvement in product development.

Work Environment

This is a first-shift, 100% onsite position based in Warsaw. The role operates within a highly regulated medical device environment focused on orthopedic technologies that restore mobility and improve quality of life. You will collaborate closely with engineering, clinical, sourcing, and manufacturing teams and work with advanced 3D design tools and testing equipment for benchtop and simulated operating room evaluations, including cadaveric studies. The culture emphasizes innovation, rigorous design control and risk management, quality, and continuous improvement, offering challenging technical work and strong opportunities for professional growth within a mission-driven setting.

This is a Contract position based out of Warsaw, IN.

The pay range for this position is $36.00 - $46.00/hr.

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.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Warsaw,IN.

This position is anticipated to close on Sep 3, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment 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 the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $36 - $46