... standards • Deliver executive-level project status updates and communications Required ... Must-have skills R&D medical device Medical Devices Medical Device R&D Biomedical Device Design ...
... standards • Deliver executive-level project status updates and communications Required ... Must-have skills R&D medical device Medical Devices Medical Device R&D Biomedical Device Design ...
... executive-level project status updates and communications Required Qualifications: Bachelor ... Must-have skills R&D medical device Medical Devices Medical Device R&D Biomedical Device Design ...
... executive-level project status updates and communications Required Qualifications: Bachelor ... Must-have skills R&D medical device Medical Devices Medical Device R&D Biomedical Device Design ...
... executive stakeholders, and help build internal device capability, processes, and governance. * Other duties as assigned. Requirements Education and Experience * B.S. in Biomedical Engineering ...
... executive stakeholders, and help build internal device capability, processes, and governance. * Other duties as assigned. Requirements Education and Experience * B.S. in Biomedical Engineering ...
... and to executive stakeholders, and help build internal device capability, processes, and governance. * Other duties as assigned. Requirements: Education and Experience * B.S. in Biomedical ...
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... and to executive stakeholders, and help build internal device capability, processes, and governance. * Other duties as assigned. Requirements: Education and Experience * B.S. in Biomedical ...
Device / Combination Product Manager
San Diego, CA · On-site
$110K - $135K/yr
... executive stakeholders, and help build internal device capability, processes, and governance. * Other duties as assigned. Requirements Education and Experience * B.S. in Biomedical Engineering ...
Device / Combination Product Manager
San Diego, CA · On-site
$110K - $135K/yr
... executive stakeholders, and help build internal device capability, processes, and governance. * Other duties as assigned. Requirements Education and Experience * B.S. in Biomedical Engineering ...
Requires strong communication, executive presence, and autonomous work style. Key Requirements ... Must have regulated industry experience (medical device ideal; health tech/consumer health ...
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Requires strong communication, executive presence, and autonomous work style. Key Requirements ... Must have regulated industry experience (medical device ideal; health tech/consumer health ...
VP, R&D - Delivery System
Irvine, CA · On-site
... executive and board reporting. Required Qualifications * BS or MS in Mechanical Engineering, Biomedical Engineering, or a related field. * 10+ years in medical device R&D, including 5+ years leading ...
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VP, R&D - Delivery System
Irvine, CA · On-site
... executive and board reporting. Required Qualifications * BS or MS in Mechanical Engineering, Biomedical Engineering, or a related field. * 10+ years in medical device R&D, including 5+ years leading ...
... Biomedical, Mechanical, or Materials Engineering. [1] * Experience: Minimum of 2 years of engineering experience in product development or manufacturing within a regulated medical device industry ...
Quick apply
... Biomedical, Mechanical, or Materials Engineering. [1] * Experience: Minimum of 2 years of engineering experience in product development or manufacturing within a regulated medical device industry ...
Senior Program Manager
$123K - $123K/yr
This role will serve as a key partner to executive leadership, functional leaders, and project ... Bachelor's degree in Life Sciences, Biotechnology, Biochemistry, Biomedical Engineering ...
Senior Program Manager
$123K - $123K/yr
This role will serve as a key partner to executive leadership, functional leaders, and project ... Bachelor's degree in Life Sciences, Biotechnology, Biochemistry, Biomedical Engineering ...
Be Seen First
Regulatory Program Manager
San Francisco, CA · On-site
$150K - $180K/yr
... executive status reporting. * Partner with Regulatory Affairs to map submission strategy into ... field (e.g., Biomedical Engineering). EXPERIENCE * 7-10+ years of medical device product ...
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Be Seen First
Regulatory Program Manager
San Francisco, CA · On-site
$150K - $180K/yr
... executive status reporting. * Partner with Regulatory Affairs to map submission strategy into ... field (e.g., Biomedical Engineering). EXPERIENCE * 7-10+ years of medical device product ...
Be Seen First
Regulatory Program Manager
San Francisco, CA · On-site
$150K - $180K/yr
... executive status reporting. * Partner with Regulatory Affairs to map submission strategy into ... field (e.g., Biomedical Engineering). EXPERIENCE * 7-10+ years of medical device product ...
Quick apply
Be Seen First
Regulatory Program Manager
San Francisco, CA · On-site
$150K - $180K/yr
... executive status reporting. * Partner with Regulatory Affairs to map submission strategy into ... field (e.g., Biomedical Engineering). EXPERIENCE * 7-10+ years of medical device product ...
Quality Engineer
San Clemente, CA · On-site
$66K - $77K/yr
Position Overview We are partnering with an innovative medical device organization to find a driven ... Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a ...
Quality Engineer
San Clemente, CA · On-site
$66K - $77K/yr
Position Overview We are partnering with an innovative medical device organization to find a driven ... Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a ...
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Our team is led by executives and investors with a proven track record of commercializing paradigm ...
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Our team is led by executives and investors with a proven track record of commercializing paradigm ...
... Executive Leadership, and acts as a senior technical representative to key medical device OEM ... Bachelor's degree in Mechanical, Biomedical, Chemical Engineering, or related technical discipline ...
... Executive Leadership, and acts as a senior technical representative to key medical device OEM ... Bachelor's degree in Mechanical, Biomedical, Chemical Engineering, or related technical discipline ...
... Executive Leadership, and acts as a senior technical representative to key medical device OEM ... Bachelor's degree in Mechanical, Biomedical, Chemical Engineering, or related technical discipline ...
... Executive Leadership, and acts as a senior technical representative to key medical device OEM ... Bachelor's degree in Mechanical, Biomedical, Chemical Engineering, or related technical discipline ...
Vice President, Operations
$225K - $260K/yr
Description Company & Job Overview Diality is a medical device company focused on developing ... The Vice President of Operations is a strategic executive responsible for leading the end-to-end ...
Vice President, Operations
$225K - $260K/yr
Description Company & Job Overview Diality is a medical device company focused on developing ... The Vice President of Operations is a strategic executive responsible for leading the end-to-end ...
Vice President, Manufacturing
Irvine, CA · On-site
Diality is a medical device company focused on developing solutions to improve lives impacted by ... The Vice President of Manufacturing is a strategic executive responsible for leading the end-to-end ...
Vice President, Manufacturing
Irvine, CA · On-site
Diality is a medical device company focused on developing solutions to improve lives impacted by ... The Vice President of Manufacturing is a strategic executive responsible for leading the end-to-end ...
... Executive Leadership, and acts as a senior technical representative to key medical device OEM ... Bachelor's degree in Mechanical, Biomedical, Chemical Engineering, or related technical discipline ...
... Executive Leadership, and acts as a senior technical representative to key medical device OEM ... Bachelor's degree in Mechanical, Biomedical, Chemical Engineering, or related technical discipline ...
Vice President, Operations
Irvine, CA · On-site
Company & Job Overview Diality is a medical device company focused on developing solutions to ... The Vice President of Operations is a strategic executive responsible for leading the end-to-end ...
Vice President, Operations
Irvine, CA · On-site
Company & Job Overview Diality is a medical device company focused on developing solutions to ... The Vice President of Operations is a strategic executive responsible for leading the end-to-end ...
Sr. Program Manager
$121K - $122K/yr
Drive executive operating rhythms, including leadership meetings, business reviews, strategic ... Bachelor's degree in Life Sciences, Biotechnology, Biochemistry, Biomedical Engineering ...
Sr. Program Manager
$121K - $122K/yr
Drive executive operating rhythms, including leadership meetings, business reviews, strategic ... Bachelor's degree in Life Sciences, Biotechnology, Biochemistry, Biomedical Engineering ...
Executive Biomedical Device information
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Full-time
Re-posted 2 days ago
Job description
Now Hiring: Senior Project Manager - R&D Medical Device New Product Development
San Clemente, CA (Hybrid)
Competitive Salary Long-Term Role
Various shifts might be available, with compensation varying based on the selected shift.
We are currently looking for a seasoned Senior Project Manager with extensive experience in Medical Device New Product Development (NPD) to lead enterprise-level R&D projects within a highly regulated healthcare setting.
The successful candidate should possess practical expertise in managing products throughout the entire medical device development process - including design inputs, verification and validation, regulatory submissions, and product launch.
Requirements
Qualifications We Seek:
• Extensive experience in Medical Device New Product Development (NPD)
• In-depth knowledge of Design Controls
• Proven background in supporting FDA 510(k), MDR, and other regulatory submissions
• Capacity to perform effectively in fast-paced and ambiguous R&D settings
• Demonstrated track record of driving alignment across cross-functional teams including R&D, Regulatory, Quality, Operations, and Supply Chain
• Experience with supporting product launch and ongoing sustaining engineering efforts
Primary Responsibilities:
• Lead complex R&D and New Product Development initiatives within FDA-regulated contexts
• Oversee project execution from initial concept through to commercialization
• Manage schedules, budgets, resources, risks, and deliverables associated with projects
• Coordinate multidisciplinary teams such as Regulatory Affairs, Quality, Manufacturing, Operations, Marketing, and Supply Chain
• Support design control activities, including product performance, assembly integrity, safety, labeling, packaging, as well as verification and validation tasks
• Collaborate with stakeholders to establish project scope, validation strategies, and requirements in dynamic development environments
• Ensure compliance of all projects with FDA, ISO 13485, GMP, and MDR standards
• Deliver executive-level project status updates and communications
Required Qualifications:
• Bachelor's degree mandatory
• Minimum of 4 years' experience in Project Management within Medical Device or regulated healthcare industries
• Experience in Design Controls and Medical Device Development Lifecycle
• Strong comprehension of NPD processes and regulatory frameworks
• Skilled in MS Project, Excel, PowerPoint, SharePoint, and other related project management tools
This role represents a fantastic opportunity for a self-driven individual who excels in early-stage product development and can lead execution across multiple teams independently.
Must-have skills
R&D medical device Medical Devices Medical Device R&D Biomedical Device Design Biomedical Devices