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Senior Process Development Engineer

Katalyst Healthcares and Lifesciences

Cincinnati, Ohio • 3d ago

Full-time

Senior Process Engineer

Amrize

Florence, Kentucky • Today

Full-time

Senior Supervising Process Engineer

Parsons Services Company

Remote • Today

Full-time

USD 125,100.00 - 225,200.00 per year

Job Details

Skills

Process Engineering
Design Documentation
Continuous Improvement
Collaboration
Marketing Operations
Research and Development
IT Management
Mentorship
Mechanical Engineering
Medical Devices
Customer Engagement
Design Controls
Risk Management
Quality Management
Product Development

Summary

Summary :
We are seeking 5 Mid to Senior Process Development Engineers with 10+ years of medical device experience to lead the development and commercialization of innovative drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, auto-injectors, and micro-infusion pump systems.
The engineer will provide technical leadership across the full product development lifecycle, from concept and design through verification, validation, regulatory approval, and commercialization.

Roles & Responsibilities :

Lead cross-functional teams in the design and development of mechanical and electro-mechanical medical devices.
Drive products from concept through commercialization, including verification, validation, and regulatory submissions.
Develop engineering specifications, design documentation, project plans, test protocols, and validation plans.
Support design controls, risk management, process validation, and continuous improvement initiatives.
Collaborate with Marketing, Operations, Quality, and R&D teams.
Provide technical leadership and mentor junior engineers.
Support FDA and international regulatory submission activities.

Education & Experience :

10+ years of medical device engineering experience.
Strong experience with electro-mechanical medical device design and commercialization.
Proven experience leading products through FDA 510(k), PMA, and CE Mark approvals.
Strong knowledge of design controls, risk management, verification, validation, and quality systems.
Experience leading cross-functional engineering/product development teams.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: a0cdc6cec052734a29085bcafa157857
Posted 9 days ago

Fitment

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Job Details

Skills

Process Engineering
Design Documentation
Continuous Improvement
Collaboration
Marketing Operations
Research and Development
IT Management
Mentorship
Mechanical Engineering
Medical Devices
Customer Engagement
Design Controls
Risk Management
Quality Management
Product Development

Summary

Lead cross-functional teams in the design and development of mechanical and electro-mechanical medical devices.
Drive products from concept through commercialization, including verification, validation, and regulatory submissions.
Develop engineering specifications, design documentation, project plans, test protocols, and validation plans.
Support design controls, risk management, process validation, and continuous improvement initiatives.
Collaborate with Marketing, Operations, Quality, and R&D teams.
Provide technical leadership and mentor junior engineers.
Support FDA and international regulatory submission activities.

Education & Experience :

10+ years of medical device engineering experience.
Strong experience with electro-mechanical medical device design and commercialization.
Proven experience leading products through FDA 510(k), PMA, and CE Mark approvals.
Strong knowledge of design controls, risk management, verification, validation, and quality systems.
Experience leading cross-functional engineering/product development teams.

Dice Id: 91116760
Position Id: a0cdc6cec052734a29085bcafa157857
Posted 9 days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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