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Medical Device Project Jobs (NOW HIRING)

System One

Medical Device Assembler

Lakewood, NJ · On-site

$16/hr

Medical Device Assembler Location: Lakewood, NJ Type: Contract To Hire Compensation: $16.00 / hr ... Ability to work the entire project duration of 6 months * For immediate consideration please call ...

BEPC INC

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Medical Device Assembler

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... project management. At BEPC, we are driven by innovation and a commitment to excellence. We take ...

New

BEPC INC

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Medical Device Assembler

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... project management. At BEPC, we are driven by innovation and a commitment to excellence. We take ...

New

BEPC INC

Medical Device Assembler

Westford, MA · On-site

$19 - $21.51/hr

Medical Device Assembler Location : Westford, MA Employment Type : Full-Time| 6 Month contract | W2 ... project management. At BEPC , we are driven by innovation and a commitment to excellence. We take ...

Bracco

Medical Device Assembler I

Eden Prairie, MN · On-site

$18.25 - $22.50/hr

The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Other duties or projects as required Qualifications (Knowledge, Skills & Abilities): Minimum * High ...

Bracco

Medical Device Assembler I

Eden Prairie, MN · On-site

$18.25 - $22.50/hr

The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Other duties or projects as required Qualifications (Knowledge, Skills & Abilities): Minimum * High ...

BEPC INC

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Medical Device Assembler

Westford, MA · On-site

$19 - $21.50/hr

Medical Device Assembler Location : Westford, MA Employment Type : Full-Time| 6 Month contract | W2 ... project management. At BEPC , we are driven by innovation and a commitment to excellence. We take ...

Prismatik

Project Manager - Medical Device

Irvine, CA · On-site +1

$81K - $115K/yr

Minimum three (3) years of experience in project management; medical device industry experience, a plus. * Demonstrated knowledge of International Organization for Standardization (ISO) and Food and ...

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Medical Device Project information

What is a medical device project?

A Medical Device Project refers to the organized effort to design, develop, test, and bring a medical device to market. This involves multiple stages, including initial research, regulatory compliance, prototyping, clinical testing, and product launch. Teams working on these projects include engineers, regulatory specialists, clinicians, and project managers. The main goal is to ensure the medical device is safe, effective, and meets all regulatory requirements before it can be used in healthcare settings.

What are the key skills and qualifications needed to thrive as a medical device project manager, and why are they important?

To thrive as a Medical Device Project Manager, you typically need a background in engineering or life sciences, experience in project management, and knowledge of medical device regulations (such as FDA or ISO standards). Familiarity with project management software (like MS Project or Asana), design control systems, and regulatory submission tools is essential. Strong leadership, problem-solving, and excellent communication skills help drive cross-functional teams and manage stakeholder expectations. These skills ensure that projects are delivered on time, meet regulatory requirements, and achieve high standards of safety and efficacy.

What are some common challenges faced by professionals working on medical device projects, and how can they be addressed?

Professionals involved in medical device projects often encounter challenges such as navigating complex regulatory requirements, ensuring interdisciplinary collaboration, and managing tight development timelines. Successfully addressing these challenges requires clear communication across engineering, regulatory, and clinical teams, as well as a thorough understanding of FDA or international standards. Adopting robust project management practices and staying up-to-date with regulatory changes can help teams remain compliant and deliver safe, effective products efficiently.

What is the difference between Medical Device Project vs Medical Device Engineer?

AspectMedical Device ProjectMedical Device Engineer
CredentialsProject management certifications (PMP), relevant industry experienceEngineering degrees (Biomedical, Mechanical, Electrical), professional engineering licenses
Work EnvironmentCross-functional teams, project planning, coordinationDesign, development, testing of medical devices
Employer & Industry UsageMedical device companies, contract manufacturersMedical device companies, R&D departments
Search & Comparison IntentUnderstanding project roles, career pathsTechnical responsibilities, engineering skills

Medical Device Project roles focus on managing and coordinating the development process, ensuring projects meet deadlines and budgets. Medical Device Engineers are responsible for designing and testing the devices themselves. Both roles are essential in the medical device industry but differ in their focus and required skills.

What cities are hiring for Medical Device Project jobs?

Cities with the most Medical Device Project job openings:

What are the most commonly searched types of Medical Device Project jobs?

The most popular types of Medical Device Project jobs are:

Medical Device Project jobs near you

Medical Device DHF Engineer

Prophecy Technologies

Indianapolis, IN • On-site

Full-time

Re-posted 12 days ago

Job description

Role Overview:
This role focuses on supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The specialist will be responsible for reviewing, updating, and maintaining critical documentation such as dFMEA, uFMEA, and Preliminary Hazard Analysis (PHA), ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
  • Support and manage Design History File (DHF) activities for medical device projects.
  • Review, update, and maintain Global dFMEA and uFMEA documentation, identifying and mitigating risks.
  • Develop and update Preliminary Hazard Analysis (PHA) in line with risk management procedures.
  • Support the creation and maintenance of product risk management files throughout the development lifecycle.
  • Prepare, review, and update Product Characterization documents, Product Specification Documents (PSD), and Critical-to-Quality (CTQ) documents.
  • Support the development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
  • Ensure robust traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
  • Collaborate cross-functionally with Design, Quality, Regulatory, Manufacturing, and Project Management teams.
  • Participate in design reviews, providing technical input on risk management and DHF compliance.
  • Support engineering change assessments and associated documentation updates.
  • Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
  • Identify documentation gaps and recommend corrective actions.
  • Support audits, inspections, and compliance activities related to design control and risk management documentation.
  • Contribute to continuous improvement initiatives for product development and design control processes.
  • Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.

Required Skills:
  • Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
  • Experience in supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
  • Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
  • Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.
  • Strong written and verbal communication skills for project plans and inter-departmental collaboration.

Qualifications:
  • Experience in medical device development environments, particularly with Design History File (DHF) and risk management processes.

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