Sr. Development Engineer

Job Title: Development Engineer – Medical Device Post-MarketJob Description

The Development Engineer will focus on post-market activities for existing medical device Design History Files, ensuring documentation is complete, accurate, and compliant. Working under the guidance of a project leader, this role manages design documentation, supports risk analysis, and drives verification and validation activities while collaborating closely with cross-functional teams. The engineer contributes directly to maintaining product quality and regulatory readiness through meticulous technical documentation and review.

Responsibilities

• Author and review existing Design History Files (DHF) for medical devices, identifying scope and documenting gaps where necessary records are missing.
• Utilize Vault systems to manage document workflows, ensuring that all design and risk documentation is properly controlled and updated.
• Generate, analyze, and update risk documentation, including Design Failure Mode and Effects Analysis (DFMEA) and risk tables, to support ongoing product safety and compliance.
• Coordinate, prepare, and conduct design reviews with cross-functional teams, including Regulatory and Quality, to drive alignment and expedite critical project tasks.
• Perform functional relationship analyses (FRA) and tolerance stack-ups to validate design robustness and manufacturability.
• Develop comprehensive protocols to test and analyze products for design verification and design validation (V&V), ensuring that performance and quality requirements are met.
• Update engineering prints and other design and manufacturing elements to reflect current product configurations and standards.
• Establish and refine process methods that meet defined performance and quality requirements for post-market design activities.
• Prepare clear, concise technical reports and documentation to support regulatory submissions, quality audits, and internal design reviews.
• Deliver effective oral presentations to communicate technical findings, project status, and recommendations to stakeholders.

Essential Skills

• Strong background in authoring and executing Design History File (DHF) documentation for medical devices.
• Familiarity with Vault systems and experience managing document workflows in a controlled environment.
• Proficiency with drafting standards and geometric dimensioning and tolerancing (GD&T).
• Ability to perform functional relationship analyses (FRA) and tolerance stack-ups for mechanical and related components.
• Experience generating and updating risk documentation such as DFMEA and risk tables.
• Ability to work effectively within cross-functional teams, including Regulatory and Quality, to expedite completion of critical project tasks.
• Strong technical writing skills for creating protocols, reports, and design documentation.
• Ability to give clear and concise oral presentations to technical and non-technical audiences.
• Proficiency with the Microsoft Office Suite for documentation, data analysis, and presentations.
• Self-starter and self-motivated work style, with strong organizational skills and attention to detail.
• Excellent communication and teamwork skills to support collaborative post-market engineering activities.

Additional Skills & Qualifications

• B.S. degree from an ABET-accredited school (or global equivalent) in Biomedical, Mechanical, or Materials Engineering, or an equivalent engineering discipline.
• Experience with medical device design verification and validation (V&V) protocol development and execution.
• Experience updating prints and other design and manufacturing elements in support of post-market changes.
• Ability to establish and refine process methods that consistently meet performance and quality requirements.
• Comfort working under the direction of a project leader while managing individual responsibilities independently.

Work Environment

This is a 100% remote position, allowing you to perform all responsibilities from your preferred location while collaborating virtually with cross-functional teams. You will work extensively with digital documentation and Vault systems, using standard office productivity tools such as the Microsoft Office Suite. The role is structured as a long-term project assignment, currently planned through April 30th, 2027, providing stability and the opportunity to support ongoing post-market activities over an extended period.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $40.00 - $53.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 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.