Documentation Specialist

Talentify; Maple Grove (MN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Excellent benefits

Paid time off

Job summary

Actalent in Maple Grove, MN seeks a Documentation Specialist to manage day-to-day engineering documentation for investigational heart valve programs in an on-site role. You will create, maintain, review, and control documents, ensuring alignment with regulatory and quality requirements.

Work with Engineering, Quality, Regulatory, Manufacturing, and Clinical teams to assure DHF/DMR compliance, support audits, and drive process improvements using EDMS/PLM tools and Microsoft Office.

Qualifications

• 35 years of experience in document control or regulated environments.
• Experience with FDA Quality System Regulations and design control.
• Hands-on with EDMS/PLM systems (EDMS, PLM, Agile, Windchill, Arena).
• Ability to coordinate document reviews and audits.
• Strong documentation skills with high attention to detail.

Responsibilities

• Create, revise, route, and maintain engineering documents within the document control system.
• Manage document change requests including ECOs and ECNs.
• Ensure DHF, DMR, and technical documentation remain current and complete.
• Coordinate document approvals and ensure timely processing of revisions.
• Support engineers with formatting and organization of technical reports and specs.
• Organize product development records throughout the full design lifecycle.
• Ensure traceability between design requirements and verification activities.
• Assist with testing, validation records, and design reviews.
• Adhere to SOPs, FDA QSR, ISO requirements, and document control procedures.
• Support audits, regulatory inspections, and quality system reviews.

Skills

Document control

Attention to detail

Cross-functional collaboration

Regulatory familiarity

Communication skills

Tools

EDMS

PLM

Windchill

Arena

Microsoft Office

Job description

About this job

Job Title: Documentation Specialist

Job Description

We are seeking a motivated and detail-oriented Documentation Specialist to manage day-to-day engineering documentation for investigational heart valve programs. In this on-site role, you ensure that technical documents, design records, and quality system documentation are accurately created, maintained, reviewed, and controlled in alignment with regulatory and quality requirements. Working closely with Engineering, Quality, Regulatory, and Operations teams, you play a critical role in maintaining document integrity, supporting product development activities, and ensuring inspection readiness.

Responsibilities

• Create, revise, route, and maintain engineering documents within the document control system.
• Manage document change requests, including Engineering Change Orders (ECOs) and Engineering Change Notices (ECNs).
• Ensure Design History Files (DHF), Device Master Records (DMR), and technical documentation remain current, accurate, and complete.
• Review documentation for completeness, consistency, and compliance with internal procedures and quality standards.
• Coordinate document approvals and ensure timely processing of revisions and updates.
• Support engineers with the preparation, formatting, and organization of technical reports, protocols, work instructions, and specifications.
• Organize and maintain product development records throughout the full design lifecycle.
• Ensure traceability between design requirements, verification activities, and associated documentation.
• Assist with maintaining records related to testing, validation, and product development activities.
• Prepare documentation packages for design reviews and key project milestones.
• Adhere to company standard operating procedures (SOPs), FDA Quality System Regulations, ISO requirements, and document control procedures.
• Support internal audits, regulatory inspections, and quality system reviews by maintaining inspection-ready documentation.
• Identify documentation gaps, discrepancies, and compliance risks and elevate issues as appropriate.
• Participate in continuous improvement initiatives to enhance document management processes and tools.
• Partner closely with Engineering, Quality, Regulatory Affairs, Manufacturing, and Clinical teams to support documentation needs.
• Coordinate document review and approval workflows across departments to ensure efficient and compliant processes.
• Communicate document status, revision progress, and outstanding actions to stakeholders in a clear and timely manner.
• Schedule documentation review meetings and maintain associated records, minutes, and action items.
• Support training efforts related to document control and engineering documentation procedures for cross-functional teams.
• 35 years of experience in document control, engineering documentation, quality systems, or regulated manufacturing environments.
• Experience working within FDA-regulated medical device, pharmaceutical, or other highly regulated industries.
• Knowledge of Design Control requirements, Design History Files (DHF), and document control processes.
• Hands-on experience with electronic document management systems (EDMS, PLM, Agile, Windchill, Arena, or similar platforms).
• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
• Strong attention to detail with the ability to consistently produce accurate, complete, and compliant documentation.
• Excellent organizational skills with the ability to manage multiple document workflows and priorities simultaneously.
• Quality-focused mindset with an understanding of traceability, compliance, and record integrity.
• Effective communication skills for collaborating with both technical and non-technical stakeholders.
• Proactive problem-solving skills to identify process improvements and resolve documentation issues.
• Team-oriented approach and ability to thrive in a collaborative engineering and product development environment.

Additional Skills & Qualifications

• Experience supporting medical device design assurance, risk management, design validation, and validation activities through documentation.
• Experience in quality engineering, new product development, or process development environments.
• Familiarity with mechanical engineering concepts and terminology to support technical documentation.
• Demonstrated ability to work effectively in a small, culture-oriented team with a focus on innovation.
• Comfort working in highly regulated environments with frequent audits and inspections.
• Ability to contribute to continuous improvement initiatives related to documentation and quality systems.

This position is based on-site in Maple Grove, MN, working closely with Engineering, Quality, Regulatory, Manufacturing, and Clinical teams in a collaborative, small, culture-oriented environment. You will use electronic document management systems (such as EDMS or PLM tools) and the Microsoft Office Suite on a daily basis to manage and maintain engineering and quality documentation. The work is performed in a professional office and engineering setting that supports investigational heart valve product development, with regular cross-functional interaction and a strong emphasis on innovation, compliance, and inspection readiness.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $85000.00 - $120000.00/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.

Excellent company benefits and paid time off.

Application Deadline

This position is anticipated to close on Oct 30, 2026.

Workplace Type

This is a fully onsite position in Maple Grove,MN.

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 [e-mail] 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.