Documentation Specialist

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

Job summary

Actalent is seeking a Documentation Specialist in Maple Grove, MN to manage day-to-day engineering documentation for investigational heart valve programs. The role focuses on creating, maintaining, and controlling technical documents to support product development and regulatory compliance.

You will collaborate with Engineering, Quality, Regulatory, Manufacturing, and Clinical teams, ensuring traceability and inspection readiness.

Qualifications

• 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.

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 SOPs, FDA QSRs, 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 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.

Skills

Document control

Engineering documentation

Quality systems

EDMS/PLM tooling

MS Office

Detail oriented

Cross-functional communication

Tools

EDMS

PLM

Windchill

Arena

Agile

Office suite

Job description

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.

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.

Essential Skills

• 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.

Work Environment

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.

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.