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Pilates Instructors, Pacific Palisades
Equinox
Los Angeles, CA
- $45 USD / hour
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ISV Partner Manager
EPIC Epicor Software
United States
…software into meaningful customer value. As an ISV Partner Manager, you will manage strategic relationships with Independent Software Vendors whose solutions Epicor brings to market…
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Construction Engineer V
AECOM
Houston, TX
- $145,000 to $165,000 USD / year
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Mining Study Program Manager
AECOM
Remote, United States
- $200,000 to $240,000 USD / year
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Added 1 min ago
Janitorial Site Manager
GDI
Glendale, KY
…environmentally friendly processes and supplies and an established global reputation, we are able to offer unrivaled client experience and…
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Airside Experience Specialist
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- $22 to $25 USD / hour
…reputation if the work continues. Report concerns to the appropriate manager and cooperate in addressing the unsafe act or…
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Senior Accounts Payable Specialist
Aersale Inc
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…This position is eligible for full benefits, as well as the Manager level annual incentive bonus…
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Account Support Representative
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Added 3 mins ago
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Part-Time Sales Lead - Famous Footwear
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Project Engineer, Overhead Contact System (Construction Engineer VII)
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MACHINE LEARNING ENGIENEER II (REMOTE)
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Manager, External Engagement
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To achieve their goals, the Manager will collaborate with numerous internal cross-functional teams, agency partners and vendors. This position reports directly to the Executive Director,…
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Onsite Manager - Adecco - Hasbrouck Heights, NJ
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Destination Program Manager 26
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Survey Manager
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…to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision…

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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