Job Title: Manufacturing EngineerJob Description
This role offers an opportunity for an experienced Manufacturing Engineer to drive compliance, quality, and efficiency in medical device manufacturing. You will focus on ensuring manufacturing processes meet EU Medical Device Regulation (EU MDR 2017/745) requirements and applicable quality and regulatory standards. The position centers on assessing, remediating, validating, and documenting manufacturing processes, while collaborating closely with Quality, Regulatory Affairs, R&D, Operations, and Supply Chain teams. You will lead process improvements, risk management activities, and technical documentation efforts to support ongoing regulatory compliance and robust manufacturing performance in a highly regulated environment.
Responsibilities
Support EU MDR compliance initiatives for legacy medical device products by reviewing and aligning existing manufacturing processes and documentation with current regulatory expectations.
Assess manufacturing processes against EU MDR requirements and identify compliance gaps, deficiencies, and areas for improvement.
Execute remediation activities to address manufacturing process deficiencies identified through MDR assessments, audits, inspections, and internal reviews.
Ensure manufacturing documentation aligns with EU MDR, applicable quality system regulations, and relevant regulatory requirements.
Support the preparation, review, and maintenance of Technical Documentation and Design Transfer documentation for medical device products.
Lead remediation projects for manufacturing processes impacted by MDR requirements, ensuring timely completion and sustained compliance.
Review and update manufacturing work instructions, process specifications, manufacturing procedures, and quality documentation to reflect current practices and regulatory requirements.
Assess existing process controls and implement improvements to ensure consistent product quality, process robustness, and regulatory compliance.
Collaborate with cross-functional teams, including Quality, Regulatory Affairs, R&D, Operations, and Supply Chain, to resolve process nonconformities and close compliance gaps.
Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes.
Create and execute process validation protocols and reports, including manufacturing process verifications and equipment qualifications.
Analyze validation data, apply appropriate statistical methods, and provide statistically sound conclusions and recommendations.
Ensure all validation and verification activities meet regulatory, quality, and customer requirements.
Lead the creation, remediation, and maintenance of Process Failure Mode and Effects Analyses (PFMEA), control plans, and process risk assessments.
Ensure PFMEAs align with process validation activities, production controls, and overall risk management strategies.
Support risk management activities in compliance with relevant ISO standards for medical devices.
Apply strong troubleshooting and root cause investigation skills to resolve process issues and prevent recurrence.
Manage multiple remediation and improvement projects simultaneously, balancing priorities and timelines in a fast-paced environment.
Communicate effectively with stakeholders at all levels, providing clear updates, documentation, and technical justifications for process changes and validation outcomes.
Essential Skills
Bachelor's degree in Engineering, such as Manufacturing, Mechanical, Biomedical, Industrial, Chemical, or a related discipline.
Minimum of 3 years of manufacturing engineering experience in a regulated medical device environment.
Demonstrated experience with EU MDR (2017/745) compliance activities, particularly as they relate to manufacturing processes and documentation.
Experience performing manufacturing process remediation to support regulatory compliance initiatives.
Strong experience developing and executing process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Experience conducting process verification activities to confirm process performance and capability.
Experience developing and executing equipment qualification protocols and authoring validation reports.
Proven experience creating, updating, and remediating Process Failure Mode and Effects Analyses (PFMEAs) and process risk assessments.
Working knowledge of medical device quality system regulations, including 21 CFR Part 820.
Understanding of Good Manufacturing Practice (GMP) requirements in a medical device @context.
Experience supporting regulatory audits and inspections, including preparation, on-site support, and follow-up actions.
Strong technical writing and documentation skills, with the ability to produce clear, complete, and compliant records and reports.
Strong understanding of medical device manufacturing processes and regulatory requirements.
Expertise in process validation, verification, and risk management methodologies.
Excellent troubleshooting and root cause investigation skills applied to manufacturing processes.
Ability to manage multiple remediation and improvement projects simultaneously while meeting deadlines.
Strong communication skills and the ability to collaborate effectively with cross-functional teams.
Ability to work independently and effectively in a fast-paced, highly regulated environment.
Additional Skills & Qualifications
Experience working with Class II and/or Class III medical devices.
Experience with sterilization, packaging, assembly, or catheter/device manufacturing processes.
Familiarity with statistical software tools and process capability analysis for interpreting validation and process data.
Experience supporting Notified Body audits and MDR transition or remediation projects.
Broad knowledge of medical device risk management practices and related ISO standards.
Demonstrated ability to adapt to evolving regulatory requirements and implement process changes accordingly.
Strong organizational skills and attention to detail in managing documentation, validation activities, and project timelines.
Work Environment
This role operates in a remote work environment, offering flexibility in location while supporting a highly regulated medical device manufacturing setting. You will collaborate with cross-functional teams through virtual meetings, digital collaboration platforms, and electronic documentation systems. Although the work is remote, you will engage closely with manufacturing, quality, regulatory, and engineering stakeholders to support on-site processes and compliance activities. The position emphasizes disciplined documentation practices, structured project management, and adherence to established quality system procedures in a virtual setting.
Job Type & Location
This is a Permanent position based out of Denver, CO.
Pay and Benefits
The pay range for this position is $57.69 - $57.69/hr.
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 Jul 24, 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.
