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Added 1 min ago
Sr. Project Manager
Clearance Center
Cambridge, MA
The Senior Project Manager will have a proven track record of independently managing high-stakes, complex programs across the full delivery lifecycle of programs which may include an Agile…
Added 1 min ago
Product Engineer
Samsung Electronics Home Appliance America
284 Mawsons Way Newberry, SC
6. Assist Product Engineering Manager in staff training [Sector Leaders currently have people management responsibilities over a team of 5 PEs]
Added 2 mins ago
Data Product Manager & Quality Specialist (Senior)
Altamira Technologies Corp.
Suitland, MD
Position: Data Product & Quality Specialist (Senior)
Added 2 mins ago
NC
Sr. Optical Engineer
Newport Corporation
Milpitas, CA
- $120,000 to $170,000 USD / year
As a Senior Optical Engineer at Spectra-Physics, Lasers Business Unit of MKS Inc, you will partner with Multi-disciplinary Internal Teams to contribute to the development of platform…
Added 4 mins ago
Lead Program Manager - FedRAMP
Mark43
Remote, United States
We are looking for a FedRAMP Program Manager to join our Security & Compliance team. This is a senior individual contributor role designed for someone who thrives at the intersection of…
Added 4 mins ago
Lead Program Manager - FedRAMP
Mark43
Boston, MA
We are looking for a FedRAMP Program Manager to join our Security & Compliance team. This is a senior individual contributor role designed for someone who thrives at the intersection of…
Added 5 mins ago
Manufacturing Process Engineer
IEA
Kenosha, WI
Collaborates with IEA Design Engineering, Production, Quality, Sales, and Senior Management on conducting research to develop new and improved processes for manufacturing.
Added 8 mins ago
J
Project Manager
Jobot
St. Louis, MO
- $120,000 to $160,000 USD / year
Project Manager - Data Center, Heavy Industrial
Added 9 mins ago
Field Sales Manager
Arrow Electronics
Washington, DC
Responsible for driving strategy and delivering results: Makes recommendations to General Manager/ Sales Director on strategy and customer plans. Through data analysis and past experience…
Added 9 mins ago
Policy Team Lead
Trinzic
Washington, DC
Bachelor’s degree in computer science, data analytics, software engineering, or related technical field and 8 years of experience
Added 9 mins ago
Senior Manager, Security Operations Center
Rubrik
Washington, DC
Rubrik is hiring a Senior Manager to lead our Security Operations Center, including our FedRAMP-authorized environment. Incident response sits at the core of what the SOC does, alongside…
Added 9 mins ago
Senior Cybersecurity Architect (Cloud)
Amentum
Washington, DC
Define AI telemetry and investigation requirements with Security Operations and Detection Engineering, then support escalated investigations, control improvements, and secure recovery when…
Added 9 mins ago
Solutions Architect - Nutanix Database Service
Nutanix
Washington, DC
The successful candidate will join the Americas Solution Specialists & Systems Engineering Organization at Nutanix - a forward-thinking group dedicated to solving complex enterprise…
Added 10 mins ago
Contract Administrator II
Washington Metropolitan Area Transit Authority
Washington, DC
…professional and technical service, construction and Architecture and Engineering (A/E) contracts for Washington Metropolitan Area Transit Authority (WMATA). The incumbent is assigned…
Added 10 mins ago
Senior Product Manager, Technical, Database Services
Amazon Development Center U.S., Inc.
Seattle, WA
- Knowledge of engineering practices and patterns for the full software/hardware/networks development life cycle, including coding standards, code reviews, source control management, build…
Added 11 mins ago
Talent Acquisition Partner
Simpson Strong-Tie Company Inc.
Columbus, OH
Simpson Strong-Tie is a leader in engineered structural connectors, software, and solutions for the building industry. We maintain a reputation as a trusted manufacturer, partner, and…
Added 12 mins ago
Sr. Director, Transformation - USG
Vantor Inc.
Herndon, VA
Bachelors Degree in a relevant field (e.g., Business Administration, Political Science, Software Engineering, Earth Sciences, Geospatial Engineering).
Added 13 mins ago
Senior Engineer (Deer Island Engineering)
Massachusetts Water Resources Authority
Winthrop, MA
Under the direction of a program manager, manages consultant selection and supervision of professional engineering consultant contracts, including the development of scope of services,…
Added 13 mins ago
Senior Program Manager, Engineering - Deer Island
Massachusetts Water Resources Authority
Winthrop, MA
Provides oral and written reports to the Manager, Engineering Services (DI) detailing results of problem investigations, proposed resolution, and economic justification for the proposed…
Added 15 mins ago
F
Staff Product Manager
Flashpoint
Remote, United States
- $174,900 USD / year
This is a senior individual contributor seat with real strategic weight. You will carry the vulnerability roadmap, work directly with customers, and set the vulnerability AI strategy for…
Added 15 mins ago
Electromechanical Technician (Aerosols)- Electrical Focus, T22, A-Team
SC Johnson
Racine, WI
As an Electromechanical Senior Technician, you will be a multi-craft maintenance technician with the skills to troubleshoot, repair and replace technical components within the manufacturing…
Added 15 mins ago
Safety Manager
Webcor Construction, LP
San Francisco, CA
The Safety Manager is responsible for managing and implementing the project safety program on one project or a portion of a large, complex project. This position provides leadership,…
Added 16 mins ago
Director, Product Legal
NetApp
San Jose · Durham · Wichita · Pittsburgh · Waltham · Seattle
This senior Product Counsel position will support technical product, engineering, and business teams throughout the product development lifecycle, with a particular emphasis on enterprise…
Added 17 mins ago
J
Facilities Manager
JLL
Hopkinsville, KY
- $7.25 USD / hour
Looking for an experienced Facilities Manager who will support several warehouse/manufacturing locations. You will manage a team of vendors and services, support projects, oversee all…
Added 17 mins ago
SI
Sr. Multi-Site Plant Manager
Signode Industrial Group
Florence, KY
- $7.25 USD / hour
…of a broad spectrum of transit packaging consumables, tools, software, and equipment that optimize end-of-line packaging operations and protect products in transit. Signode brings this…

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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