Jobs in the United States

25+ jobs

Save this search

Added just now
Systems Engineer/Configuration Analyst, Junior- IBDSS II
Semper Valens Solutions
Huntsville, AL
Semper Valens Solutions is looking for a Systens Engineer/Configurations Analyst to join our systems engineering team responsible for changes to documentation, technical drawings, technical…
Added just now
Guest Services Manager
Monterey Beach Hotel
Monterey, CA
The Guest Services Manager is responsible for ensuring the operation of the Guest Services department in an attentive, friendly, efficient and courteous manner, providing all guests with…
Added 1 min ago
BF
Safety Manager
Blount Fine Foods
Fall River, MA
- $80,000 to $90,000 USD / year
…prepared foods. We are an engaging team, bringing restaurant-quality products to America including single-serve grab-n-go fresh soups, mac & cheese, and entrées in grocery stores across the…
Added 1 min ago
Operations Analyst I
Palmetto GBA
Columbia, SC
…discontinuance and other methods. Recommend installations of new systems/procedures. Reviews organizational functions and structure to avoid overlapping or duplication. May provide security…
Added 1 min ago
Sales Floor Dept Supervisor - Hardware-Tools
Lowes
Roanoke, VA
All Lowe’s associates deliver quality customer service while maintaining a store that is clean, safe, and stocked with the products our customers need. As a Sales Floor Department…
Added 2 mins ago
RP
Field Auditor Premium Insurance
ReSource Pro
Glendale, CA
- $17.25 to $18.67 USD / hour
Collaborating with colleagues and leaders to uphold quality standards and a positive, respectful workplace culture.
Added 2 mins ago
General Manager
Dans Overhead Doors & More Acquisition LLC
Pleasant Hill, IA
The General Manager will be responsible for all aspects of operations to ensure efficient and effective service delivery. This role requires a combination of technical expertise in garage…
Added 2 mins ago
Field Diesel Mechanic-Sign-On Bonus Available!
Titan Machinery
Williston, ND
Diagnostic, Repair, and Technical Expertise: Perform accurate diagnosis, repair, and reconditioning of machine systems and components in accordance with manufacturer specifications; provide…
Added 3 mins ago
UT
QA/QC Manager - DPF - Stewartville
United Therapeutics Corporation
Stewartville, MN
- $100,000 to $140,000 USD / year
The QA/QC Manager provides operational and tactical leadership for the on-site Quality Assurance and Quality Control Microbiology function at the Designated Pathogen-Free (DPF) Facility in…
Added 3 mins ago
I
Lead Product Marketing Manager
Imprint
New York City, NY
- $200,000 to $240,000 USD / year
…annual spend, and most still run on decades-old legacy bank systems. Imprint is the modern alternative: flexible, embeddable, and built for how people actually pay today. Backed by Kleiner…
Added 3 mins ago
AM
Hotel Food and Beverage Manager
AFP Management Corp
Utica, NY
- From $25 USD / hour
Participate in the Manager on Duty (M.O.D.) program and attend all required pre- and post-convention conferences.
Added 4 mins ago
CC
Manager, Purchasing
Cache County School District
North Logan, UT
- $74,238 to $110,393 USD / year
Develop and oversee effective purchasing, strategic sourcing, bidding, negotiation, and contracting processes and systems to ensure cost-effective, timely contracting with trade partners…
Added 4 mins ago
Operations Manager
ThompsonGas LLC
Manassas, VA
The Operations Manager’s primary responsibility is to plan and supervise the day-to-day operations of their branch location. This includes, but not limited to, managing the product…
Added 5 mins ago
Project Manager
ACSC Auto Club Of Southern Calif
Costa Mesa, CA
The Life Project Manager is responsible for leading and managing complex projects from initiation through completion, ensuring delivery on time, within scope, and within budget. Key…
Added 5 mins ago
IS Clinical Apps Manager
Lexington Medical Center
West Columbia, SC
…design, definition, build, deployment and administration of the systems and applications that comprise the Electronic Health Record. In addition, the Clinical Applications Manager will work…
Added 5 mins ago
Social Worker | Counselor - TC West Highschool
Grand Traverse County
United States
…people who are committed to providing responsive, effective quality service to our up-north community. We strive to be a leader in innovative, effective, collaborative, and sustainable…
Added 5 mins ago
Account Executive Uniform - Sales
Vestis
Pompano Beach, FL
Updating his/her manager weekly with prospect information and status of movement in the prospecting stages and next action(s);
Added 6 mins ago
Manufacturing Systems Engineering/Program Lead
AeroVironment, Inc.
Albuquerque, NM
AV is seeking an experienced Manufacturing Systems Engineering/Program Lead to provide technical leadership for manufacturing engineering activities across multiple programs. This role will…
Added 6 mins ago
Lead Program Manager - FedRAMP
Mark43
Remote, United States
We’re looking for a Federal Compliance Program Manager with extensive experience leading compliance programs in SaaS or technology companies. This role requires strong technical…
Added 6 mins ago
Lead Program Manager - FedRAMP
Mark43
Boston, MA
We’re looking for a Federal Compliance Program Manager with extensive experience leading compliance programs in SaaS or technology companies. This role requires strong technical…
Added 6 mins ago
Clinical Risk and Safety Investigations Specialist
Elara Caring
Dallas, TX
…like home, and that’s why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever…
Added 7 mins ago
Global Supply Chain Manager
Dynetics, Inc
Remote, United States
A radar program is racing toward a milestone. A critical RF component is running behind. A subcontract worth millions sits at the center of it all, with compliance clauses to honor, a…
Added 7 mins ago
Property Manager II (Laurel Hill Apartments)
WinnCompanies
Shelby, NC
…it all possible. As an award-winning owner, developer, and manager of high-impact, mixed-income apartment communities, we are proud to be one of the nation’s leading managers of multifamily…
Added 8 mins ago
Director, Managed Marketing
Toast
Remote, United States
As Director, Marketing Services, you will own Toast’s managed marketing program from end to end. You’ll set the strategy, service model and operating standards for the business, and lead a…
Added 9 mins ago
Transcon Manager
Expeditors
Laredo, TX
Actively participate in the optimization of systems and tools and continuously improve the efficiency, productivity and quality of the service.

CAIRE

Project Manager - MGC

Saint Paul, MN, United States

Apply About employer

Applications open in a new tab.

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.

Apply About employer

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

Report this job