Senior Product Development Engineer
3 weeks ago
At Tempo Therapeutics, we are pioneering a new era in tissue engineering and regenerative medicine with our cutting edge Microporous-Annealed-Particle (MAP) technology platform. Our team is developing next generation biomaterials to build precision scaffolds for use in surgical reconstruction, organ regeneration, and even vaccine technology. Our mission is to harness the power of immunomodulation and use material science to transform the landscape of medical technology.
This is a unique opportunity to work in a fast-paced and challenging environment, while being an integral part of a team that is developing material science technology shaping the future of medicine. Our team is driven by the goal of changing patient lives for the better, and the successful candidate will share that driving force.
Job Summary:
The Senior Product Development Engineer works within Research & Development and is responsible for leading the device design efforts and development of manufacturing processes for medical devices to be transferred to CMO for manufacturing according to cGMP. Manages and executes process technology transfer, process validations, PFMEA, and CAPA’s from clinical to commercial production stages according to ISO standards and FDA regulations. Manages external vendors and service partners to ensure compliance, timelines, and budget are maintained. Supports development of innovative final product presentation solutions for delivery of novel biomaterial products.
Responsibilities:
Position will perform the following in a leading role:
-Manage medical device design control process per ISO 13485 and 21 CFR 820
-Draft and maintain SOP’s
-Develop and execute process validations
-Develop and execute PFMEA
-Support vendor audits
-Maintain and help develop device master file (DMF) and design history file (DHF)
-Supports ongoing application of risk management per ISO 14971
-Transfer manufacturing process to CMO
- CMO’s to ensure compliance for clinical and commercial manufacturing programs
- routine laboratory housekeeping, support inventory management, shipping, receiving, reconciliation activities.
- duties as assigned/needed
- to Director of Research and Development
Qualifications:
Bachelor’s degree in chemistry or other life science related field
10+ years’ experience working within a quality system, direct experience working within cGMP to support full product manufacturing lifecycle from pre-clinical, clinical, and commercial stages. Experience interacting with FDA to support inspections desired.
Extensive knowledge and experience in (must have):
-Good manufacturing practices per 21 CFR 211
-Process validation
-PFMEA
-Manufacturing product lifecycle management
-Design controls via 21 CFR 820 and ISO 13485
-ISO 14971 Application of Risk Management
-Equipment validation
-MS Suite
Additional knowledge and experience in (pluses):
-Aseptic processing and validations
-Fill and finish
-Complex formulations
-Tangential flow filtration (flat sheet and hollow fiber)
-Sterile filtration
-
Sr Product Development Engineer
4 weeks ago
San Diego, United States Mainstay Medical International plc Full timeThis is an onsite position in San Diego, CA. Mainstay Medical Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States,...
-
Senior Staff Product Engineer
2 days ago
San Diego, United States Elevate Semiconductor Full timeElevate’s mission is to serve our semiconductor and system test customers by providing world class test integrated circuits (ICs) that address the industry’s most complex ATE challenges. We strive to exceed our customer’s expectations, now and well into the future, through designing the lowest power/highest density solutions, with the goal of providing...
-
Senior Staff Product Engineer
2 days ago
San Diego, United States Elevate Semiconductor Full timeJob DescriptionJob DescriptionElevate’s mission is to serve our semiconductor and system test customers by providing world class test integrated circuits (ICs) that address the industry’s most complex ATE challenges. We strive to exceed our customer’s expectations, now and well into the future, through designing the lowest power/highest density...
-
Senior Product Development Engineer
3 weeks ago
San Diego, United States Tempo Therapeutics Full timeAt Tempo Therapeutics, we are pioneering a new era in tissue engineering and regenerative medicine with our cutting edge Microporous-Annealed-Particle (MAP) technology platform. Our team is developing next generation biomaterials to build precision scaffolds for use in surgical reconstruction, organ regeneration, and even vaccine technology. Our mission is...
-
Senior Product Development Engineer
3 weeks ago
San Diego, United States Tempo Therapeutics Full timeAt Tempo Therapeutics, we are pioneering a new era in tissue engineering and regenerative medicine with our cutting edge Microporous-Annealed-Particle (MAP) technology platform. Our team is developing next generation biomaterials to build precision scaffolds for use in surgical reconstruction, organ regeneration, and even vaccine technology. Our mission is...
-
San Mateo, United States Gilead Sciences Full timeThe Senior Quality Engineer will play a critical role in ensuring the quality and compliance of our combination products throughout the product development lifecycle. This individual will collaborate with cross-functional teams, providing expertise i Product Development, Quality Engineer, Engineer, Quality, Development, Product, Technology
-
Senior Product Engineer
2 weeks ago
San Diego, United States ELEVATE SEMICONDUCTOR, INC Full timeElevate’s mission is to serve our semiconductor and system test customers by providing world class test integrated circuits (ICs) that address the industry’s most complex ATE challenges. We strive to exceed our customer’s expectations, now and well into the future, through designing the lowest power/highest density solutions, with the goal of providing...
-
Senior Manager Development Engineering
7 days ago
San Diego, United States Origis Energy Full timeOrigis Energy is seeking a Manager or Senior Manager Development Engineering to provide technical support and management for early-stage conceptual design and optimization in renewable energy projects as they flow from inception through EPC contracting. The role involves coordinating and contracting with engineering consultants, maintaining internal layouts,...
-
Senior Product Engineer
2 weeks ago
San Diego, United States Elevate Semiconductor Full timeElevate’s mission is to serve our semiconductor and system test customers by providing world class test integrated circuits (ICs) that address the industry’s most complex ATE challenges. We strive to exceed our customer’s expectations, now and well into the future, through designing the lowest power/highest density solutions, with the goal of providing...
-
Senior Product Engineer
2 weeks ago
San Diego, United States ELEVATE SEMICONDUCTOR, INC Full timeElevates mission is to serve our semiconductor and system test customers by providing world class test integrated circuits (ICs) that address the industrys most complex ATE challenges. We strive to exceed our customers expectations, now and well into the future, through designing the lowest power/highest density solutions, with the goal of providing the...
-
Senior Product Engineer
2 weeks ago
San Diego, United States Elevate Semiconductor Full timeElevate’s mission is to serve our semiconductor and system test customers by providing world class test integrated circuits (ICs) that address the industry’s most complex ATE challenges. We strive to exceed our customer’s expectations, now and well into the future, through designing the lowest power/highest density solutions, with the goal of providing...
-
Product Development Engineer
2 weeks ago
San Diego, United States Vista Outdoor Full timeWork with Product line manager, external vendors, and internal resources to define and develop products for a successful and timely release. Work with Product line manager to define product and features. Create detailed specifications for product. De Product Development, Development Engineer, Golf, Development, Engineer, Mechanical, Manufacturing
-
Process Development Engineer
2 weeks ago
San Diego, United States Medical Instrument Development Laboratories, Inc. Full timePosition Summary The Process Development Engineer will be responsible for overseeing all production activities within the manufacturing area, ensuring the smooth operation of processes and maintaining overall efficiency. Your expertise, experience and insights will be instrumental in refining our processes and playing a vital role in meeting daily and...
-
Senior Product Safety
2 weeks ago
San Diego, United States ASML Holding N.V. Full timePerform, coordinate, and document Hazard Analyses and Risk Assessment of modules, subsystems, and systems. Coordinate external resource evaluations and certifications of products, accessories, subassemblies, and components. Review and edit compliance Compliance, Engineer, Safety, Product, Senior, Skills, Manufacturing
-
Senior Software Engineer
1 week ago
San Diego, United States Werfenlife SA. Full timeSenior Software Engineer (Qt User Interface Development) Country United States Shift 1st About the Position Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and...
-
San Diego, CA, United States Kudzu Interactive, Inc. Full timeSenior Software Engineer - Back End (#03222023MA) Senior Software Engineer - Back End ( #03222023MA) Work with a team of local and globally-distributed Software Engineers/Developers, Product Management, Quality Assurance, and other professionals to design, develop and deliver software application products built to meet requirements for company’s mobile...
-
Senior Java Developer
7 days ago
San Diego, United States ObjectWin Technology Full timeJob Title: Senior Software Engineer Location: San Diego CA 92127 Duration: 12 Months This is a fast paced, high-visibility engineering position with SIE's payment, fraud, and commerce platform engineering organization helping to establish a linear scale, highly available, fault-tolerant, globally distributed commerce services platform. As a Software...
-
Senior Engineering Technician
2 weeks ago
San Diego, United States Acord (association For Cooperative Operations Research And Development) Full timeThe Senior Engineering Technician with the San Diego County Water Authority (SDCWA) will provide technical, paraprofessional engineering support to engineering project managers in the planning, design, permitting and construction management of SDCWA capital improvement projects and existing facilities maintenance; provide a full range of detailed...
-
Senior Product Manager, Marketplace
3 weeks ago
San Bruno, United States The Product Folks Full timeFifty years ago, Sam Walton started a single mom-and-pop shop and transformed it into the world's biggest retailer. Since those founding days, one thing has remained consistent: our commitment to helping our customers save money so they can live better. Today, we're reinventing the shopping experience and our associates are at the heart of it. You'll play a...
-
San Diego, CA, United States Tillster Full timeSenior Software Engineer - Back End (#03222023MA) Work with a team of local and globally-distributed Software Engineers/Developers, Product Management, Quality Assurance, and other professionals to design, develop and deliver software application products built to meet requirements for company’s mobile and online food ordering and e-commerce payment...