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Added just now
Sr Network Operations Engineer
loanDepot
Irvine, CA
…procedures; collaborates closely with Network Engineering and Cybersecurity teams on secure enterprise designs; and ensures duties are performed in accordance with company policies and…
Added 1 min ago
IT Business Partner - Engineering
TE Connectivity
United States
Ensure initiatives are aligned with ICT governance, architecture standards, and cybersecurity requirements – including between Project Management and Engineering.
Added 5 mins ago
OC
IT Product Owner Complaints, Global
Olympus Corporation of the Americas
Westborough, MA
- $122,362 to $171,307 USD / year
Ensure platform compliance with enterprise governance, cybersecurity, data integrity, computer system validation, and applicable regulatory requirements, including FDA QMSR, 21 CFR Part 11,…
Added 10 mins ago
CL
Cybersecurity Engineer
Career Listings
Chantilly, VA
- $140,000 to $160,000 USD / year
SarelaTech is seeking a Cybersecurity Engineer to provide integrated cybersecurity and systems engineering support for cloud collaboration services delivered to DoW customers. This role…
Added 13 mins ago
SS
Program Manager
SUMARIA SYSTEMS LLC
Colorado Springs, CO
- $100,000 to $120,000 USD / year
Program Manager, Journeyman – Space Force / System Delta 85
Added 16 mins ago
C
Software Engineer Data & AI II (Full Time) – United States
Cisco
San Jose, CA
- Full-time
Qualifying education and work experience should be in Computer Science, Computer Engineering, Cybersecurity, IT, or a related program.
Added 23 mins ago
Senior Events Experience Manager
Palo Alto Networks, Inc.
CA
In order to be the cybersecurity partner of choice, we must trailblaze the path and shape the future of our industry. This is something our employees work at each day and is defined by our…
Added 25 mins ago
Network Analyst II
Texas A&M University - Texarkana
Texarkana, TX
Collaborates with TAMUS Cybersecurity Shared Services to implement security controls, policies, standards, and best practices.
Added 31 mins ago
SO
Information Technology Manager 3
State of Connecticut
Hartford, CT
- $131,219 to $178,920 USD / year
…technology leader for the position of Information Technology Manager 3 within Core-CT. The Core-CT division runs the State of Connecticut's PeopleSoft based Enterprise Resource Planning…
Added 32 mins ago
Critical Situation Manager (CSM)
LEIDOS, INC.
Meridian, ID
Leidos is seeking a Critical Situation Manager (CSM) to support efforts for the NMCI/SMIT program to perform network engineering support for a broad range of programs including planning,…
Added 32 mins ago
NEN Solution Engineering – Senior Voice Engineer
LEIDOS, INC.
Remote, United States
This position supports multiple DoD contracts and serves as a cross-program technical authority for voice engineering. As a Level T5 engineer, the incumbent will influence solutions that…
Added 32 mins ago
Material Project Manager
LEIDOS, INC.
Huntsville, AL
It’s Wednesday afternoon in Huntsville. A priority component is trending late, a supplier needs a firm answer, and the program manager is asking for a path forward before the next status…
Added 39 mins ago
Director, AI Product Mgr - Low Code
Edward Jones
United States
The Director, AI Product Manager - Low Code is responsible for building and scaling AI products in approved low-code environments that enable business and functional teams to solve…
Added 40 mins ago
Systems Engineer, SME
Odyssey Systems Consulting Group, Ltd.
Colorado Springs, CO
…may be assigned the roles of Product Owner and Product Line Manager for an Agile Release Team (ART) and/or System Delivery Team within the program…
Added 47 mins ago
IT Integration Program Manager; Remote
Connection
Remote, United States
Connection has a fantastic opportunity through our Technical Staffing division for an IT Integration Program Manager. This is a contract position with benefits.
Added 50 mins ago
Senior Manager - Identity & Access (Remote) Management
Employment Application
IL
The Senior Manager– Identity and Access Management is a technical leader responsible for implementing transformative capabilities for our workforce and enterprise Identity and Access…
Added 50 mins ago
Associate Indirect Procurement Manager- Rotational Program
Rochester, NY · Chicago, IL
The Associate Manager, Indirect Procurement Rotational Program is a full-time development role designed to build broad capabilities in category management, strategic sourcing, stakeholder…
Added 52 mins ago
Security Manager Senior, Identity Controls Governance
PNC Bank NA
United States
The Manager, Identity Controls Governance will provide leadership and oversight for enterprise Identity and Access Management (IAM) controls, helping ensure access is appropriately…
Added 52 mins ago
Security Manager Senior, Identity & Access Management Operations
PNC Bank NA
Farmers Branch, TX
…opportunity to contribute to the company’s success. As a Security Manager Senior within PNC's Technology organization, you will be based in Dallas, TX; Denver, CO; Phoenix, AZ; Birmingham,…
Added 52 mins ago
Help Desk Manager
Peraton
Robins AFB, GA
Peraton is hiring an experienced Help Desk Manager for its' Product Data Systems Support (PDSS) program located at Robins Air Force Base.
Added 54 mins ago
SO
Energy/Utilities Engineer 3
State of Washington
Lacey, WA
- $84,528 to $110,952 USD / year
Reporting to the Telecommunications Section Manager, the Energy/Utilities Engineer 3 (E/UE 3) investigates, evaluates, and analyzes potentially interrelated engineering, legal, policy, and…
Added 59 mins ago
Information System Security Officer (ISSO)
CACI, INC.-FEDERAL
Annapolis Junction, MD
CACI is seeking an experienced Information Systems Security Officer (ISSO) to support cybersecurity operations, risk management, and compliance activities within a Department of Defense…
Added 1 hour ago
IT Audit Senior Associate - Digital Risk Services
Elliott Davis Advisory, LLC
Charlotte, NC · Chattanooga, TN · Raleigh, NC · Columbia, SC · Charleston, SC · Nashville, TN · Greenville, SC
Master's degree in Information Systems, Accounting, Cybersecurity, or another relevant discipline.
Added 1 hour ago
IT Audit Associate - Digital Risk Services
Elliott Davis Advisory, LLC
Charlotte, NC · Chattanooga, TN · Raleigh, NC · Columbia, SC · Charleston, SC · Nashville, TN · Greenville, SC
Master's degree in Information Systems, Accounting, Cybersecurity, or another relevant discipline.
Added 1 hour ago
Manager, Enterprise Strategy
Mastercard
Purchase, NY
Bachelor’s degree required, MBA and/or advanced degree from a top-tier program preferred

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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