Jobs in the United States

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Added 3 mins ago
Senior Manager, Data Analytics Enablement
Labcorp
Durham, NC
Establish and enforce best practices for data engineering, data governance, data quality, security, and operational support.
Added 4 mins ago
Sr. Manager Environmental Health and Safety 1
TE Connectivity
FAIRVIEW, NC
The Sr. Manager, EH&S provides strategic and operational leadership for Environmental Health & Safety across the Fairview and Arden manufacturing sites. This role is responsible for…
Added 5 mins ago
Director, Reliability Hardware Systems
IREN
Remote, United States
…racks, networking, and storage. Reporting to the [Reporting Manager], this leader directs multiple system-level reliability teams, drives root-cause investigations of complex field…
Added 16 mins ago
FI
Molding Automation Technician - Day Shift
Flextronics International USA, Inc.
IL
- $26.03 to $35.14 USD / hour
Reports To: Senior Process Engineering Manager / Automation Lead
Added 19 mins ago
K
Technical Program Product Manager
Kforce
Austin, TX
- $83 to $91 USD / hour
We are seeking a Product Cost Manager to own bill of material cost for our advanced robotic platforms from first prototype through high volume production. This role owns the number. You…
Added 21 mins ago
R&D Manager
Yamaha Motor
Lebanon, MO
As R&D Manager, you will lead product development initiatives, guide a talented engineering team, and collaborate closely with Manufacturing, Quality, Purchasing, Marketing, and Operations…
Added 27 mins ago
Senior Process Engineer
Yanfeng Human Resources
Romulus, MI
Provides support on new product launch tooling, providing the manufacturing input for development of new process and improvements to existing processes and tooling.
Added 31 mins ago
RA
Senior Network Engineer, Network Access Security
Rockwell Automation (USA)
Mayfield Heights, OH · Chelmsford, MA · Mequon, WI · Eden Prairie, MN · Milwaukee, WI
- $119,360 to $179,040 USD / year
As a Senior Network Engineer, Network Access Security, you will join our enterprise network and security engineering team. In this role you will help own the design, security, and…
Added 36 mins ago
Plant Controller
Stow
Holland, MI
…plant utilizing their cost accounting expertise specific to manufacturing. The ideal candidate is data driven and has the ability to not only analyze information, but effectively…
Added 39 mins ago
Director, MRO Procurement
Florida Crystals / ASR Group
West Palm Beach, FL
…with Vice Presidents, plant General Managers, members of the Engineering Department and with numerous other departments/leaders across the organization, including Maintenance, Plant…
Added 41 mins ago
Logistics Program Mgr., AWS Cloud Logistics
Amazon Data Services, Inc.
Austin, TX · Bellevue, WA · Florence, KY
As a Transportation Operations Manager, you will serve as the connective tissue between operations execution and performance measurement across both logistics and warehousing services. You…
Added 42 mins ago
A
Senior Job Captain
Actalent
Phoenix, AZ
- $75,000 to $85,000 USD / year
Complete drawings and documentation within agreed-upon timeframes and proactively communicate any delays to the Project Manager or Project Architect.
Added 42 mins ago
Project Controls Manager
Leidos
The Woodlands, TX
Leidos Engineering is seeking an experienced Project Controls Manager (PCM) to support a centralized capital project oversight organization responsible for evaluating and assessing…
Added 43 mins ago
Senior Manager, Project Management
Capital One
Plano, TX
We are seeking a Senior Manager of Project Management who is passionate about masterfully managing cross-functional stakeholders and balancing project scope and timelines. In this exciting…
Added 44 mins ago
Senior Manager, Product Marketing
Applied Materials, Inc
Santa Clara, CA
Partner closely with Engineering, Manufacturing, and Sales teams to define, develop, and launch new products while enhancing existing offerings. Translate market requirements into…
Added 45 mins ago
Software Delivery Lead
Baker Hughes
Houston, TX
Have experience within a consulting organization at the Engagement Manager, Project Leader, or Senior Manager level, or within an industrial software or digital solutions company in a…
Added 45 mins ago
Technical Program/Project Management IV
Applied Materials
Austin, TX
…impact in Austin Operations. As an E4 Technical Program/Project Manager in OLDP, you will rotate through key operations areas, build Applied-specific manufacturing and business context, and…
Added 45 mins ago
Technical Program/Project Manager IV
Applied Materials
Austin, TX
…impact in Austin Operations. As an E4 Technical Program/Project Manager in OLDP, you will rotate through key operations areas, build Applied-specific manufacturing and business context, and…
Added 52 mins ago
Plant Controller
Holland, MI
…plant utilizing their cost accounting expertise specific to manufacturing. The ideal candidate is data driven and has the ability to not only analyze information, but effectively…
Added 53 mins ago
Studio Engineer – Project Manager Track
Vonmod
Denver, CO
This is a career, not a seat. You start as a Studio Engineer and master drafting and engineering. As you prove that, you take on project management on your own projects. With a sustained…
Added 55 mins ago
LH
Production Supervisor
Lactalis Heritage Dairy Inc
Walton, NY
- $75,000 to $85,000 USD / year
…operational improvements. Under direction of the Production Manager, the Production Supervisor is responsible for the day-to-day manufacturing operations for an assigned area and…
Added 56 mins ago
Advanced Mechanical Design Engineer
Aerospace
Phoenix, AZ
You will provide engineering support to the largest Honeywell Aerospace repair and overhaul facility globally, design and develop new ideas and solutions for current products repairs,…
Added 59 mins ago
Senior Manager, Product Marketing
Applied Materials
Santa Clara, CA · Santa Clara
Partner closely with Engineering, Manufacturing, and Sales teams to define, develop, and launch new products while enhancing existing offerings. Translate market requirements into…
Added 1 hour ago
Manufacturing Engineering Manager
NEWAGE INDUSTRIES INC
Southampton, PA
As Manufacturing Engineering Manager with NewAge Industries, you'll lead a team focused on optimizing processes, advancing manufacturing technologies, and driving operational excellence…
Added 1 hour ago
Staff Engineer, NPI
Kohler Co.
KOHLER, WI
Act as the primary manufacturing engineering authority on assigned NPD/NPI programs, shaping manufacturing strategy, process design, and execution models to ensure products are Right the…

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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