The Opportunity: Recognized expert with broad expertise in mechanical design engineering, new product development and design transfer with responsibility for resolving significant technical issues as well as providing di…
Skills: Mechanical Design, New Product Development, Design Transfer, Medical Device Regulations, Project Management
The Aerospace Corporation is the trusted partner to the nation’s space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally funded research and development ce…
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Senior
If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. Day - 08 Hour (United States of Americ…
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Skills: Clinical Pharmacy, Drug Compounding, Patient Care, Pharmacokinetics, Medical Therapeutics
Description: Job Description Summary: The Simulation Educator (SE) is under the direct supervision of the Director of the Health Sciences Simulation Center. Simulation Educators support simulation-based learning (SBL) an…
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Career CategoryOperationsJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious …
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Sr. Aerospace Engineer - Performance and Design Job Summary: Empirical Systems Aerospace, Inc. (ESAero) is seeking a full-time Senior Aerospace Engineer - Performance and Design, to join our team in San Luis Obispo, CA. …
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Senior+
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Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$131k–$261k/yr
Full-time
bachelor degree, postgraduate degree
Posted 10d ago
~40 hrs/week
Responsibilities
Lead the design, development, and validation of complex medical devices while managing technical project plans and budgets. Provide technical supervision and mentoring to the mechanical engineering team and collaborate with cross-functional departments to ensure regulatory compliance.
Requirements
Requires a Bachelor's degree in mechanical engineering or a related field with at least 10 years of relevant engineering experience. Extensive knowledge of medical device regulations (ISO, FDA) and expertise in mechanical design and manufacturing processes are essential.
Full job description
The Opportunity:
Recognized expert with broad expertise in mechanical design engineering, new product development and design transfer with responsibility for resolving significant technical issues as well as providing direction for new technology and product development activities with a broad impact to the company goals. Works on the design and development of significant new products. Key decision-maker in identifying areas of technology for potential implementation into our products and processes. Leads the technical supervision and project management of complex engineering projects and activities. Develops networks involving cross-functional and cross-departmental groups (Operations, Marketing, Quality, Regulatory) as well as communication to senior and executive management.
What you will do:
Specify, design, verify and validate new mechanical designs, in accordance with applicable medical regulatory standards.
Support high-level technical investigation of manufacturing line issues.
Responsible for the development of technical project plans and schedules covering all engineering activities, meeting all design control and product development SOP requirements
Works in the development and management of resource plans, budgets, schedules, etc.
Lead the development of product specifications, FMEAs, DOEs, verification and validation protocols and plans.
Responsible for managing resources, the creation of project schedules and setting and maintaining budgets.
Communicates effectively and participates in cross functional development teams.
Participates in technical design reviews of mechanical design, hardware, PCBA interface, mechanical assemblies, production processes, product design and requirements documents.
Writing, submittal, and approval of Engineering Changes, as required.
May review and approve ECs.
Act as independent reviewer on programs in which not directly involved.
Responsible for utilizing and maintaining the effectiveness of the quality system.
Ensure that product designs, components and materials meet all applicable standards
Responsible for compliance with applicable Corporate and Divisional Policies.
Development and execution of new medical devices, processes, equipment, materials, verification and validation Implement approved Design Control procedures for product development in accordance with FDA guidelines.
Provide mentoring, technical guidance for mechanical engineering team.
Required Qualifications:
Bachelor’s degree in mechanical engineering or equivalent engineering or scientific discipline. Master’s degree is preferred.
Minimum 10 years related experience in engineering.
Strong technical experience in mechanical engineering, with excellent written and verbal communication skills.
Excellent knowledge of general engineering principles. Extensive knowledge of regulations for medical device development (ISO15197, ISO134851, ISO13485, FDA) desired.
Extensive understanding of processes and materials used in the development and manufacturing of medical devices is ideal.
Preferred Qualifications:
Extensive experience in all of the following: Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis.
Working in a development environment with an emphasis on medical device product development.
Writing product requirements and design specifications.
Supporting equipment/facility/process commissioning and validation required.
Working on a development team with an emphasis on minimizing time to market.
Design for manufacture of low-cost, high-volume disposable products.
Extensive knowledge and understanding of GxP, ISO and medical device regulations and the development and implementation of new products in a regulated environment desired.
Extensive experience working in cross-functional team environments is required.
The base pay for this position is $130,700.00 – $261,300.00. In specific locations, the pay range may vary from the range posted.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
Terms of Use: https://www.abbott.com/social-media-terms-of-use.html
Privacy Policy: https://abbo.tt/privacy
Offices: 100 Abbott Park Road, Abbott Park, Illinois 60064-3500, US
How much do Science & Research jobs in California pay?
Based on 11509 listings with disclosed salaries, most science & research jobs in California pay between $101k–$250k per year. Individual offers vary with seniority, company size, and specialization.
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There are currently 18,233 open science & research positions in California listed on Clera. New openings are added daily as companies post roles.
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