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Life Sciences Finance Reinvention Partner - Sr. Manager
Accenture LLP Company
NY
…Finance, Gross‑to‑Net Sales Finance, and Product Costing, to lead complex, multi‑workstream transformations that align Finance strategy with the Life Sciences value chain. Your ability to…
Added 2 mins ago
AL
Mission Critical Associate Field Engineer - PLC - Automated Logic - Sullivan, IN
Automated Logic Contracting Sv
Lisle, IL
- $43,500 to $87,500 USD / year
Project Documentation: Maintain accurate Allen-Bradley PLC checkout sheets, I/O test records, redlines, deficiency logs, network notes, and daily updates while communicating controls status…
Added 2 mins ago
Regional Technical Sales Consultant - US Northeast Region
Hitachi Global
Remote, United States
…assembly, digital monitoring equipment, electrical testing, controls, repairs, modifications, LTC’s, oil processing, oil testing, and breaker mechanisms - will be essential as you help…
Added 2 mins ago
SPO Manager - Drywall
Turner Construction
Seattle, WA
Lead and manage Self-Perform Operations (SPO) unit and staff.
Added 4 mins ago
Senior Accountant, Fixed Assets & Capital Expenditures
ERMCO-ECI Bristol
Bristol, WI
…experienced technical resource for fixed asset accounting and capital project financial management across the organization. This role bridges day-to-day accounting execution and advanced…
Added 4 mins ago
Director, Solutions Engineering
STACK Infrastructure US
Remote, United States
STACK is seeking a Director, Solutions Engineering, to lead client technical engagements through lease execution. This role combines technical precision with strategic leadership to ensure…
Added 4 mins ago
Corporate Safety Coordinator
DeMaria Building Company
Novi, MI
…management of company safety. Maintain, promote, and enforce project site safety in accordance with company policies and procedures, MIOSHA requirements, local, state and federal laws.…
Added 4 mins ago
MM
AWS 3RD (F/S/S/M)- Maintenance Technician Sr/Lead
Manufacturing Maintenance Solutions (MMS)
East Peoria, IL
- $30 to $33 USD / hour
We're looking for an experienced Senior Lead Maintenance Technician who knows how to troubleshoot difficult equipment problems, lead other technicians, and still enjoys being hands-on.
Added 6 mins ago
Global Supply Manager, Datacenter Cooling Equipment (Starlink)
SpaceX
Austin, TX
Lead supplier innovation programs - challenge and collaborate with vendors on custom high-efficiency designs, modular cooling packages, advanced controls integration, low-GWP refrigerants,…
Added 6 mins ago
RH
Finance Manager
Robert Half
Arlington, VA
- $65 to $85 USD / hour
…government contracting sector. This Long-term Contract position will lead essential finance and accounting activities for a newly established entity, ensuring accurate reporting and strong…
Added 7 mins ago
Senior VDC Engineer
James G. Davis Construction Corp.
Rockville, MD
Manages Virtual Construction project setup and model administration, including folder structures, naming conventions, file processing, and development of complex federated models in…
Added 7 mins ago
EHS Engineer
James G. Davis Construction Corp.
Rockville, MD
Evaluates adequacy of hazard controls and collaborates with project teams to improve planning
Added 7 mins ago
Assistant EHS Manager
James G. Davis Construction Corp.
Rockville, MD
Collaborates with project teams and trade partners to revise or strengthen controls
Added 7 mins ago
Branch Manager
Johnstone Supply LLC
NORTH CHARLESTON, SC
…including Daikin/Goodman, Bosch, Copeland, Honeywell, Johnson Controls, and Fujitsu, to provide contractors with world-class products, technical expertise, and quality…
Added 8 mins ago
RH
Accounting Manager (Construction)
Robert Half
Weymouth, MA
- $115,000 to $120,000 USD / year
…ensuring accurate financial reporting, maintaining strong internal controls, and partnering with leadership to support business operations and profitability. This is an excellent…
Added 8 mins ago
Associate Specialist, Technical Operations Engineer (On-site)
Merck
Rahway, NJ
…Engineering, Quality, Facilities, Maintenance, Automation, capital project teams, and other program stakeholders. The position combines hands-on manufacturing support with technical problem…
Added 8 mins ago
Technical Operations Engineer (On-site)
Merck
Rahway, NJ
…Engineering, Quality, Facilities, Maintenance, Automation, capital project teams, and other program stakeholders. The position combines hands-on manufacturing support with technical problem…
Added 8 mins ago
HP
IT Operations Engineer II
Hensel Phelps
Reston, VA
- $79,230 to $104,700 USD / year
…and optimizing all local and wide area network connections, project servers, associated software, and communication links. IT Operations Engineers II are also responsible for providing…
Added 8 mins ago
Senior Cost Accountant
Rosendin
Pflugerville, TX
As a Senior Cost Accountant, you will independently manage and analyze project and operational costs, providing critical financial insights that drive profitability and inform strategic…
Added 8 mins ago
Senior Cost Accountant
Rosendin
Coppell, TX
As a Senior Cost Accountant, you will independently manage and analyze project and operational costs, providing critical financial insights that drive profitability and inform strategic…
Added 9 mins ago
Boilermaker Superintendent
Black & Veatch Family of Companies
Cartersville, GA
…major subcontractor supervision and field engineering. Ensures project requirements and expectations are met with regards to craft and supervisory performance, direct hire craft…
Added 9 mins ago
Director, HR Technology and Workforce Analytic
Columbus McKinnon Corporation
Charlotte, NC
Lead enterprise HR digital-transformation initiatives and establish governance for prioritization, investment decisions, delivery, change management, and adoption.
Added 9 mins ago
Senior Scheduler - Data Center Construction
Turner & Townsend
Tysons Corner, VA
Our capabilities include program, project, cost, asset and commercial management, controls and performance, procurement and supply chain, net zero and digital solutions.
Added 9 mins ago
Staff Engineer, Facilities Engineering
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MA
…support facilities equipment installation, troubleshooting, and project construction for site locations in Wilmington and Chelmsford, MA. This role will be based out of Wilmington, MA. The…
Added 9 mins ago
Sr. Clinical Research Coordinator - Breast Oncology
UCSF
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…of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual…

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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