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Corporate Safety Manager (Copy)
We Are Overwatch
United States
Our mission is the construction and management of state-of-the-art data centers with the precision and reliability this industry demands. From high-end engineers to seasoned professionals,…
Added just now
Production Supervisor - Night Shift
Plastipak Packaging Inc. (US)
Jackson Center, OH
Report on the effectiveness and performance of production activities to the production manager.
Added 1 min ago
CNA- Home Health Aide, Hospice
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Charleston, SC
…with company match, direct deposit and employee assistance…
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- $19.25 USD / hour
…quality, and audits. This role will work with the Compliance Manager and Cultivation team to ensure that we are proactive in addressing potential issues, maintaining compliance throughout…
Added 2 mins ago
Senior IT Project Manager
Graham Technologies
North Las Vegas, NV
Graham Technologies is seeking an experienced Senior IT Project Manager to be the primary point of contact for our customers' Federal IT Program Managers. This role involves managing…
Added 5 mins ago
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Quality Assurance Manager
Actalent
North Mankato, MN
- $100,000 to $150,000 USD / year
Job Title: Quality Assurance ManagerJob DescriptionWe are seeking an experienced Quality Assurance Manager who will oversee the inspection and calibration personnel. This role involves…
Added 5 mins ago
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Operations Manager
Actalent
Deer Island, OR
- $57 to $82 USD / hour
Job Title: Operations ManagerJob DescriptionThe Operations Manager serves as the key operational leader and trusted partner to the Plant General Manager, overseeing more than half of the…
Added 7 mins ago
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Program Manager
Pavion
AR
- $110,000 to $160,000 USD / year
Pavion and our family of companies are seeking a talented and motivated Program Manager to join our security business unit.
Added 9 mins ago
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Sr Technical Program Manager, Data
Hyperscience
Remote, United States
- $122,000 to $206,500 USD / year
As a Senior Technical Program Manager for Data, you will serve as the operational and strategic anchor for our Data Foundations initiatives. In this role, you will combine technical program…
Added 9 mins ago
Director of Infrastructure Operations
Virginia Community Colleges
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Ability to balance cloud productivity enablement with strong governance, least-privilege access, data protection, compliance requirements, and measurable service reliability.
Added 10 mins ago
Lead Software Development Engineer
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…eligible for additional compensation that may include an incentive…
Added 13 mins ago
Data Center Site Program Manager
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…everyone, whether down the street or across the globe. As a Program Manager at Google, you’ll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to…
Added 15 mins ago
Reliability Program Manager
Milacron
Batavia, OH
Milacron is looking for a Reliability Program Manager to join our team in Batavia, OH. In this position, you will be responsible for the day-to-day management and growth of Milacron’s…
Added 18 mins ago
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Trainer
Planet Fitness - Baseline Fitness
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- $14.25 USD / hour
Respond to member questions and concerns in a timely and professional manner and elevate to Team Lead, MIT or Club Manager as needed.
Added 19 mins ago
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Process Engineer
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Kent, WA
- $81,000 to $95,000 USD / year
Reporting to the Plant Engineering Manager, you will drive operational excellence and continuous improvement within the Business Unit by leading Daily Management Systems, improving…
Added 19 mins ago
Test Engineering Manager
Vertiv
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Test Engineering Manager – 1PH UPS Product Development
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Assistant General Manager - Ashton School Nutrition
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…nutritious, and made with purpose. As an Assistant Food Service Manager, you’ll help lead the charge in creating a food program that’s more than just meals - it’s a key part of every…
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Excellent time management and reliability, demonstrating punctuality and dependability.
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Environmental Health & Safety Manager
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The EHS Manager will engage with the team to drive a proactive culture across the manufacturing facility. This leader will partner with the operations team to evolve Wabtec’s EHS.…
Added 25 mins ago
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Report directly to the Warehouse Manager, Warehouse Supervisor, or assigned operational leader.
Added 26 mins ago
Telecom Site Technician
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…Field Services team. Under the direction of the Field Service Manager but working largely independently without and/or with limited direct supervision, provide remedial repair, preventive…
Added 31 mins ago
Vice President, Program Executive
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…oversight and management of the MTA’s $68.4 billion Capital Program, C&D ensures the efficient delivery of critical infrastructure projects that support the region’s vast transportation…
Added 32 mins ago
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Program Manager
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Citadel Security USA is seeking an experienced Program Manager to lead the performance and day-to-day administration of assigned contracts. This leadership position is responsible for…
Added 32 mins ago
Licensed Practical Nurse, LPN - Home Health Visits
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…with company match, direct deposit and employee assistance…
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CAIRE

Project Manager - MGC

Saint Paul, MN, United States

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Job details

Experience: Minimum of 5 years of experience in medical device product development with at least 3 years in a dedicated project or program management role.
Posting language: English

Original job description

Summary/Objective MGC Diagnostics is seeking a skilled and driven Project Manager to lead the development of cardiorespiratory diagnostic medical devices. This role is responsible for cross-functional leadership of product development from concept through global commercialization, managing internal teams across multiple locations and supporting engagement with technical and operational external partners. The successful candidate will drive execution within a structured, stage-gate development environment while ensuring compliance with global regulatory and quality standards. Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lead full lifecycle project management of new product development (NPD) for Class II FDA-regulated medical devices, from concept through design transfer and commercial launch.
Develop and maintain integrated project plans, timelines, resource forecasts, risk registers, and budgets aligned to program objectives.
Ensure compliance with global medical device regulations including FDA (21 CFR Part 820), ISO 13485, ISO 14971, IEC 60601, and other applicable international standards.
Drive execution of product development through a stage-gate process, ensuring quality system deliverables.
Coordinate activities across cross-functional internal teams, including R&D, QA/RA, Operations, and Marketing, located in multiple geographic regions.
Collaborate with external partners and suppliers, supporting technical and operations leads to manage vendor deliverables and timelines.
Facilitate formal design reviews, technical documentation review, and risk management activities.
Prepare and deliver regular program status updates to senior leadership, including project health, milestones, and risk mitigation strategies.
Track departmental and project performance through established KPIs, and prepare regular status reports for leadership and key stakeholders.
Support regulatory submission activities (e.g., 510(k), technical file, global registrations) in collaboration with Regulatory Affairs.
Promote a culture of accountability, continuous improvement, and cross-functional problem-solving.

Competencies/Success Factors

Detail Orientation
Project/ Task Management
Results Focus/ Output Orientation
Personal Energy/ Enthusiasm
Team Orientation
Interpersonal Communication
Leadership
Problem Solving

Supervisory Responsibility

None. Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and photocopiers. Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
Occasional lifting up to 50 lbs., occasional heavier lifting.
Occasional pushing, pulling and handling of materials.

Travel

Very limited travel< than 5% Required Education and Experience

Bachelor’s degree in Engineering, Biomedical Sciences, or a related technical field.
Minimum of 5 years of experience in medical device product development with at least 3 years in a dedicated project or program management role.
Strong understanding of medical device design controls, regulatory requirements, and product development life cycle in a highly regulated environment.
Proven success leading projects involving electromechanical systems, embedded software, and firmware.
Expertise in waterfall development methodologies and stage-gate execution.
Proficient in project management tools (e.g., MS Project, Smartsheet) and MS Office Suite.
Exceptional organizational, leadership, communication, and stakeholder management skills.

Preferred Education and Experience

PMP certification or equivalent project management training.
Experience with global regulatory markets, including FDA, EU MDR, Health Canada, ANVISA, PMDA, TGA, and MHRA.
Experience with cybersecurity, data privacy, and interoperability considerations in connected medical devices.
Familiarity with IEC 62304, ISO 14971, and ISO 10993 standards.
Knowledge of design for manufacturing (DFM), design for reliability (DfR), and working with contract manufacturers.

Additional Eligibility Qualifications

None required for this position. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. MGC Diagnostics is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

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More about this job

Skills

Leadership
Regulatory compliance
Project management
Medical devices
Medical device regulations
Geographic areas
Documentation
Risk management
Regulatory affairs
Process improvement
Problem solving
SuccessFactors
Manage schedule of tasks
Communication skills
Heavy lifting
Biomedical science
Program management
Firmware
Waterfall development
Microsoft Project
Smartsheet
Microsoft Office
Stakeholder management
PMP

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