Job Details

Technical Writer – Regulated Engineering and Medical Device Documentation

This role focuses on creating, organizing, and maintaining high-quality technical documentation that supports engineering and product development activities in a regulated environment. You will collaborate closely with engineers, quality professionals, and cross-functional teams to ensure all documentation meets corporate and regulatory standards throughout the product development lifecycle.

Responsibilities

• Write, revise, organize, edit, and proofread technical engineering and development documentation, including design and verification deliverables.
• Co-author and contribute to engineering documents in partnership with engineers and cross-functional project teams.
• Develop document structures and create initial drafts using source material provided by technical subject matter experts.
• Apply corporate and regulatory documentation standards to ensure compliance throughout the product development lifecycle.
• Organize raw technical data into clear, usable tables, figures, and summaries that support design and verification activities.
• Initiate and manage document change requests using document control systems in accordance with established procedures.
• Act as a subject matter expert for document management tools and processes, providing guidance and support to project teams.
• Support development and design milestone reviews by preparing and maintaining required documentation and records.
• Maintain complete and accurate project records, including ownership and upkeep of Design History File (DHF) documentation.
• Collaborate with engineers, quality, and cross-functional development teams to ensure documentation accurately reflects design intent and regulatory expectations.
• Ensure that all documentation remains current, traceable, and aligned with design controls and change management requirements.

Essential Skills

• Bachelor's degree in Technical Writing, Engineering, Life Sciences, or a related field, or equivalent experience.
• Minimum of 6 years of experience preparing regulated technical documentation in a medical device, engineering, or regulated industry environment.
• Demonstrated experience writing and maintaining technical documentation in a structured, design-controlled environment.
• Minimum of 5 years of experience collaborating with engineers, quality, and cross-functional development teams.
• Proven ability to apply corporate and regulatory documentation requirements, including design controls and change management systems.
• Strong ability to organize complex technical information into clear, concise, and accurate documentation.
• Technical writing experience in regulated environments, particularly in engineering or medical device contexts.
• Familiarity with regulatory expectations for documentation across the product development lifecycle.

Additional Skills & Qualifications

• Experience supporting medical device product development documentation.
• Familiarity with Design History Files (DHF) and development milestone reviews.
• Experience with electronic document management and change control systems.
• Hands-on experience with Windchill or similar document management tools.
• Strong attention to detail and commitment to documentation accuracy and completeness.
• Effective communication and collaboration skills when working with cross-functional teams and subject matter experts.

Work Environment

You will work in a structured, design-controlled environment that emphasizes regulatory compliance, documentation accuracy, and traceability across the product development lifecycle. The role involves frequent collaboration with engineering, quality, and other cross-functional team members, often using electronic document management and change control systems, including tools such as Windchill. The environment prioritizes clear communication, adherence to established documentation standards, and disciplined use of document control processes to support medical device and engineering projects.

Job Type & Location

This is a Contract position based out of Maple Grove, MN.

Pay and Benefits

The pay range for this position is $40.00 - $48.00/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.