Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices……
Proficiency in the use of statistical and quality engineering tools such as exploratory data analysis, basic statistics, Gage R&R, Analysis of Variance, Failure……
As a Process Engineer, you'll design, develop, and optimize the manufacturing processes behind our antimicrobial, conductive, and EMF shielding products.…
Serves as a recognized technical expert in design engineering, new product development, and design transfer, resolving complex technical challenges and driving……
Ability to operate in fast-paced, regulated manufacturing environments. The ideal candidate will lead complex, cross-functional projects involving software……
This role requires strong technical expertise, regulatory knowledge, and leadership capabilities to manage cross-functional teams and ensure compliance with FDA……
BS in computer science, engineering, mathematics, information management, or related field with 12+ years of industry experience. 2 Days a Year to Volunteer.…
Support program and project leads to ensure adequate oversight and control of vendors providing development, test or technical services for the project and are……
Responsible for all software functional requirements and design specifications documents, including architecture, design diagrams, and implementation documents.…
Bachelor’s degree in engineering, Life Sciences, or related field (master’s preferred). Establish, standardize, and continuously improve design control, risk……
Bachelor’s or Master’s degree in a relevant technical or scientific field. Partner with cross-functional stakeholders across software, genomics, and pathology……
Support change impact assessments across engineering, manufacturing, and quality domains. Support risk assessments, FMEA/dFMEA and design reviews.…
Early-career GSMs will own a focused portfolio under mentorship; senior and staff GSMs will own multi-commodity strategy across both programs, lead the most……
Early-career engineers will own a focused portfolio of parts with strong mentorship; senior and staff engineers will own multi-commodity strategy across……
Bachelor's degree in a technical field (bioinformatics, genomics, computer science, molecular biology, biomedical engineering, or related) or equivalent……
Proven ability to lead cross-functional quality initiatives, manage and develop QA teams, and influence stakeholders across engineering, product, and clinical……
Advanced degree (MS, PhD) in engineering, statistics, computer science, or a related quantitative field, or a recognized regulatory certification such as RAC (……
Strong understanding of enterprise AI capabilities, including generative AI, agents, retrieval augmented generation, classification, and automation, sufficient……
Valid driver’s license and ability to travel domestically and internationally as required. We will actively recruit, develop, and promote people from a variety……
Medical Safety or Cross-functional projects: Plays an active role in driving and contributing to Medical Safety priorities and initiatives, aligning goals and……
Offers onsite, hybrid and field work environments. As an individual contributor you will influence the science and practice of all medical safety activities……
Understanding of medical device regulations, including ISO 13485, FDA 21 CFR Part 820 (for design controls and quality management), as well as best practices……
Ensure design controls for new product development and improvement project activities, including risk management, design V&V, product software validation,……
Minimum BS/BA in science, engineering, or technical field. If you're looking for a role where you own something significant, build toward regulatory inspection……
This role combines strong upstream product leadership with people management, requiring an experienced product professional who can mentor and develop product……
This person will work across internal electrical, firmware, signal processing, mechanical, clinical, manufacturing, and external ASIC design/vendor teams to……
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Job Description:
Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ultrasound/imaging systems.
Skill Requirement:
Strong understanding of: Design controls & product lifecycle
Systems engineering