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Remote Medical Device Project Manager Jobs in Michigan

Aptar Group

Business Development Manager

Midland, MI · On-site +1

Remote position; Preferably Midwest or East Coast in US (Western Europe possible) Travel: yes ... Develop a strong understanding of Medical Device market dynamics, including regulatory and ...

Strata Information Group

Project Manager

Detroit, MI · Remote

$90K - $115K/yr

This is a remote position; qualified candidates must live and be eligible to work in the USA. Some travel is required. Responsibilities of the Project Manager: * Provide overall leadership for ERP ...

Hooker DeJong

Project Manager

Muskegon, MI · On-site +1

... remote location. This position has full responsibility for managing all aspects of projects varying in size and complexity. Prepares project plans for assigned projects, regularly monitors progress ...

Hooker DeJong

Project Manager

Grand Rapids, MI · On-site +1

PROJECT MANAGER Are you ready to take your career to the next level with a company that's been ... Willingness to travel and the ability to thrive in a hybrid remote work environment.What We're ...

Hitachi

Project Manager

Holland, MI · On-site +1

Project/Program Management Job Schedule: Full time Remote: No The Opportunity: JR Automation, a Hitachi Group Company, is driven to deliver customer success worldwide. We provide intelligent ...

Motorola

Project Manager

Three Rivers, MI · Remote

This is a remote position with approximately 50% travel. Qualified candidates can reside anywhere ... Incentive Bonus Plans * Medical, Dental, Visionbenefits * 401K with Company Match * 10 Paid ...

Integral Blue

Project Manager

Auburn Hills, MI · On-site +1

$5.2K/mo

This position will work out of Integral Blue's Auburn Hills, Michigan office with remote work ... Project Management Professional (PMP) * Bicsi Certifications (RCDD, DCDC, OSP, and RTPM) Health and ...

IPS Technology Services

Project Manager

Detroit, MI · On-site +1

REMOTE (has to relocate to SE MI) Long Term Contract TOP SKILLS : Agile Healthcare Project Management Top 3 Required Skills/Experience: • Project management (5+ years) • Health, or Insurance ...

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Remote Medical Device Project Manager information

What are the key skills and qualifications needed to thrive as a Remote Medical Device Project Manager, and why are they important?

To thrive as a Remote Medical Device Project Manager, you need strong project management skills, a background in engineering or life sciences, and knowledge of medical device regulations, often supported by a PMP certification or similar credential. Familiarity with project management tools like Microsoft Project, collaboration platforms, and regulatory submission systems (such as FDA eCTD) is commonly required. Exceptional communication, leadership, and problem-solving abilities help in leading cross-functional remote teams and managing stakeholders. These skills are crucial for ensuring regulatory compliance, timely product development, and effective coordination in a dispersed work environment.

What are some common challenges faced by Remote Medical Device Project Managers, and how can they be addressed?

Remote Medical Device Project Managers often face challenges such as coordinating cross-functional teams across different time zones, maintaining clear communication with stakeholders, and ensuring regulatory compliance from a distance. These challenges can be addressed by establishing regular virtual meetings, using project management tools to track progress, and implementing standardized documentation practices. Building strong relationships with team members and fostering an open communication culture are also key to overcoming these hurdles and ensuring project success.

What does a Remote Medical Device Project Manager do?

A Remote Medical Device Project Manager oversees the planning, execution, and completion of projects related to medical devices, all while working remotely. They coordinate cross-functional teams, manage timelines and budgets, ensure regulatory compliance, and communicate with stakeholders to keep projects on track. Their role is crucial for ensuring that new medical devices are developed efficiently and safely, meeting both company goals and industry standards.

What is the difference between Remote Medical Device Project Manager vs Remote Medical Device Quality Assurance Specialist?

AspectRemote Medical Device Project ManagerRemote Medical Device Quality Assurance Specialist
CertificationsPMP, CAPM, or equivalent project management certificationsISO 13485 Lead Auditor, CQE, or similar quality assurance certifications
Work EnvironmentOversees project timelines, teams, and deliverables remotely within medical device companiesEnsures compliance, audits, and quality processes remotely in medical device manufacturing or development
Employer & Industry UsageUsed by medical device firms managing product development projects remotelyCommon in companies focusing on quality standards and regulatory compliance remotely

The Remote Medical Device Project Manager focuses on managing project timelines, teams, and deliverables remotely, ensuring successful product development. In contrast, the Remote Medical Device Quality Assurance Specialist concentrates on maintaining quality standards, conducting audits, and ensuring regulatory compliance remotely. Both roles require specialized certifications and are vital in the medical device industry, often working in similar remote environments but with distinct responsibilities.

What are popular job titles related to Remote Medical Device Project Manager jobs in Michigan? For Remote Medical Device Project Manager jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Remote Medical Device Project Manager jobs in Michigan look for? The top searched job categories for Remote Medical Device Project Manager jobs in Michigan are:
Remote Medical Device Project Manager jobs near you
Project Manager - Healthmark QMS, Defined Term (Remote in EST)

Project Manager - Healthmark QMS, Defined Term (Remote in EST)

Getinge

Lansing, MI • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 6 days ago

Getinge rating

9.3

Company rating: 9.3 out of 10

Based on 14 frontline employees who took The Breakroom Quiz

9th of 421 rated machine equipment manufacturers

Job description

With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Project Manager - Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones. Key deliverables include the development of project timelines, project team assembly, managing the schedule and maintaining effective communication through the project. This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time.
Job Responsibilities and Essential Duties:
  • Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS workstreams.
  • Apply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines.
  • Develop and maintain project-level RAID logs, status dashboards, and executive-level reporting cadence.
  • Facilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders.
  • Lead project coordination across the following QMS enhancement areas: Product Development Process, Receiving Inspection, Complaints & Vigilance, Validation, Device History Records (DHRs), Inspection & In-Process Controls, Corrective and Preventive Action (CAPA), and Training.
  • Support SOP development, gap closure documentation, and audit-readiness activities within scope.
  • Develop and present structured status reports to project teams and senior leadership on a defined cadence.
  • Escalate risk and issues proactively; recommend resolution paths with supporting analysis.
  • Contribute to the ongoing development of PMO tools, templates, and governance processes within Healthmark's program management function.
  • Identify process improvement opportunities within the QMS implementation approach and recommend enhancements.
  • Collaborate with Quality Assurance and Regulatory Affairs to ensure all project deliverables meet FDA 21 CFR Part 820 / QMSR and ISO 13485:2016 requirements.
  • Proficiency in Microsoft Project and/or equivalent project scheduling tools (Smartsheet, Monday.com); strong Microsoft 365 skills (Teams, SharePoint, Excel).

Required Knowledge, Skills and Abilities:
  • Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026.
  • Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle.
  • Demonstrated hands-on experience with the following QMS process areas: Product Development Process / Design Controls, Receiving Inspection, Complaints & Vigilance / MDR reporting, Validation (IQ/OQ/PQ), Device History Records, Inspection and In-Process Controls, CAPA, and Training.
  • Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous.
  • Demonstrated experience leading complex, multi-workstream projects within a formal project management framework (PMI PMBOK preferred).
  • Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials.
  • Experience managing cross-functional teams in a matrixed organizational environment without direct line authority.
  • Excellent written and verbal communication skills; ability to present complex regulatory and project information clearly to both technical and executive audiences.
  • Proven ability to influence, align, and lead cross-functional stakeholders without direct supervisory authority.
  • Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments.

Minimum Requirements:
  • Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related field required.
  • Master's degree or advanced technical credential a plus.
  • Minimum 5 years of experience in project or program management roles within the medical device industry.
  • Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485 in a regulated medical device environment.
  • Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions or regulatory remediation projects is strongly preferred.
  • PMP (Project Management Professional) certification is highly desired.

Quality Requirements:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
  • Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
  • Attend all required Quality & Compliance training at the specified interval.
  • Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:
  • Primarily office/hybrid environment; use of computer, telephone, and related office accessories to complete assignments.
  • May work extended hours during peak milestones or audit preparation cycles.
  • Occasional domestic travel may be required (estimated up to 20-25% depending on site-based activities).
  • Physical requirements: ability to sit/stand at a workstation for extended periods; occasional lifting up to 20 lbs.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The salary range for this position is between $120,160 to $150,000 per year depending on experience and location.
#LI-MV1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Parental and Caregiver Leave
  • Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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About Getinge

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Dr Wayne, NJ, US

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