Sr. Product Development Engineer
Katalyst Healthcares and Life Sciences
Roles & Responsibilities :
- uthor and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF).
- Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle.
- Support product development and technology transfer from early development through clinical and commercial manufacturing.
- Translate user needs into functional requirements and design outputs, including support of Human Factors Engineering activities.
- Develop and support design outputs, specifications, packaging, and verification activities.
- Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA.
- Contribute to requirements management, quality systems, and risk management tools/processes to support development activities.
- B.S. or M.S. in Engineering or related discipline.
- 5-10 years of experience in a regulated medical device or combination product environment.
- Experience with combination products, preferably strong drug delivery systems experience.
- Strong knowledge of design controls, DHF management, and product lifecycle processes.
- Experience with risk management in accordance with ISO 14971.
- Familiarity with FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820.
- Strong technical writing, communication, and organizational skills.
- Experience JAMA and Windchill software
- bility to work independently and manage multiple projects in a fast-paced environment.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Sr. Product Development Engineer in Boston, MA vacancy
- ...for combination drug-device and biologic products, including Design History Files (DHF).... ...the product lifecycle. Support product development and technology transfer from early... ...outputs, including support of Human Factors Engineering activities. Develop and support design...Senior
Katalyst CRO
Boston, MA4 days ago $76.43k - $130.15k
...Senior Product Develompent Engineer page is loaded## Senior Product Develompent Engineerlocations: Boston, MA, UStime type: Full timeposted on... ...experienced and creative‑thinking Senior Biomedical Product Development Engineer to join our multidisciplinary Research &...SeniorHourly payTemporary workWorldwideMonday to FridayFlexible hoursHaemonetics Software Solutions
Boston, MA4 days ago$86.3k - $165.8k
...About Us SharkNinja is a global product design and technology company, with a diversified... ..., youll fit right in. The Product Development organization at SharkNinja drives our... ...team is composed of product marketers, engineers, and consumer advocates—all united in...SeniorTemporary workLocal areaFlexible hoursShift workSharkNinja
Needham Heights, MA1 day ago- ...Job Description: Senior Product Development Engineer Boyd Corporation is a market leader and manufacturer of high-performance cooling products for use in the aerospace, military, alternative energy and medical markets. Our continued growth has created an immediate...SeniorImmediate startRemote work
Boyd Company
Woburn, MA3 days ago $85k - $130k
...and a shared passion for what’s next, this is the right place to build a fulfilling career. The Senior Currency Administration Product Development Specialist assists in the leadership of product development efforts across the Global foreign exchange business line....SeniorFull timeWork experience placementWork at officeLocal area- ...Job Description Product Development Engineer - Orthopedic Medical Devices Boston, MA Hybrid We are seeking an orthopedic Product Development Engineer with to support next-generation orthopedic surgical technologies focused on Hip, Knee, and shoulder applications...
Medical Device Recruiters Inc
Boston, MA3 days ago - ...Duration: 6-12 months Start Date: 06/02/2024 Job Description: Our medical device client north of Boston, MA needs a Product Development Engineer with 5+ years of medical device experience to go through all physical copies of their DHFs to ensure they are all...
3B Staffing LLC
Boston, MA2 days ago $91.4k - $187k
...to be a pioneering force, driving the development and design of state-of-the-art RDMA clusters... ...Bachelor’s degree in CS or related engineering field with 5+ years of Network Engineering... .... Excellent judgment in influencing product roadmap direction, features, and...SeniorTemporary workFlexible hoursOracle
Boston, MA3 days ago- A global investment firm is hiring an Investment Principal to join their Public Markets Team in New York. The role requires a strong understanding of public markets and involves supporting senior investment professionals with research activities. Key responsibilities include...Senior
Partners Capital
Boston, MA4 days ago $86.3k - $165.8k
...Responsibilities: Drive new product development for the Ninja Outdoor category, based onsite at our Needham, MA headquarters , from early... ...Collaborate closely with cross‑functional teams including engineering, industrial design, and marketing to translate consumer needs...SeniorTemporary workLocal areaFlexible hoursShift workSharkninjaoperatingllc
Needham, MA21 hours ago- ...A leading healthcare institution in Boston seeks a Sr. Principal Scientist to oversee operations in a GMP lab, focusing on the production and quality control of radiopharmaceuticals. The ideal candidate will have extensive experience in aseptic operations, knowledge of...Senior
The University of Texas MD Anderson Cancer Center
Boston, MA4 days ago $140k - $195k
...human potential. As a Senior Mechanical Engineer at WHOOP, you will play a pivotal role in advancing the design and development of WHOOP’s innovative hardware solutions. You... ...the boundaries of technology by driving product innovation from conceptual prototypes to manufacturing...SeniorFull timeContract workWork at officeRelocationWhoop
Boston, MA1 day ago$126.07k - $170.56k
Career Category Process Development Job Description Join Amgen’s Mission of Serving Patients... ...; pre-IND through commercial production. The successful candidate will have a strong... ...diverse team of synthetic chemists, chemical engineers and analytical chemists to develop...SeniorFull timeContract workFlexible hours- Massachusetts General Hospital - - Responsibilities: Coordinate scheduling and intake to optimize patient access across clinics; Assist callers with routine inquiries and triage; Perform scheduling, check-in, check-out duties and manage patient records in EPIC; Act as ...Senior
Massachusetts General Hospital
Boston, MA21 hours ago - A global biopharmaceutical company is seeking a Senior Principal Scientist to lead drug discovery efforts in muscle biology. The position emphasizes supervising junior scientists, managing projects, and advancing translational research. Candidates should possess a PhD ...SeniorWork at officeRemote work
UCB
Cambridge, MA21 hours ago - ...capable of making significant contributions. This includes all phases of the donor cycle, from discovery to stewardship, and the development of individualized engagement strategies that align with the organization's mission. Collaboration with the CEO, CDO, board members...Senior
Confidential
Boston, MA21 hours ago - Massachusetts General Hospital - 52 Second Avenue - Responsibilities: Perform patient reception and administrative coordination; Manage patient scheduling, check-in and check-out duties; Support operating room scheduling and surgical scheduling tasks; Handle patient billing...Senior
Massachusetts General Hospital
Watertown, MA3 days ago - ...culture. Candidates should have 10-15 years of experience across various human capital functions, including talent acquisition and development. The firm values proactivity and strong judgment, offering a competitive compensation package. The ideal candidate will thrive in...Senior
Partners Capital
Boston, MA21 hours ago - A leading technology firm in Boston seeks a Senior Industry Principal to advise C-suite stakeholders on supply chain transformation. This remote position requires 10-15 years of experience in consulting or industry leadership. The ideal candidate will possess deep expertise...SeniorRemote work
Kinaxis
Boston, MA21 hours ago $130k
...Job Description Job Description InnoTECH Staffing is looking to hire a fulltime / permanent Senior Product Development Engineer / Scientist for an advanced materials late stage start-up company in the Greater Boston area. Candidates must be able to work onsite...SeniorPermanent employmentFull time- ...Sr. Solutions Engineer - Boston At SentinelOne, we are driven by a clear purpose: to give the advantage to those who secure our future. As AI reshapes how organizations build, operate, and innovate, the responsibility to protect them becomes more critical than ever...Senior
- B2B Informatica Developer B2B Informatica Developer is needed with expert level Informatica B2B tool knowledge with rich experience on B2B development tools (like Power center, Data transformation, B2B DX Console, Informatica MFT and ILM).Senior
Samprasoft
Boston, MA3 days ago $110k
...Victory Capital Management, Inc. seeks Sr Quantitative Analyst in Boston, MA to dvlp & implement quant models to be used in trading & portfolio mgmt of fixed income instruments. Reqmts: Masters in Math, Fince, Bus. Analytics, Quant Mgmt or rel. field & 4 yrs of progressively...SeniorRemote workWork from homeVictory Capital Management
Boston, MA1 day ago$34.38 per hour
Senior Executive Assistant The primary function of the Senior Executive Assistant is to oversee all administrative and communications functions and provide direct support managing and prioritizing daily calendar and all related materials, preparing and responding to...SeniorBack Bay Staffing Group
Boston, MA7 days ago$179k - $236k
...PK study design, bioanalytical method development, and translational biomarker strategy.... ...designed to restore full-length protein production in diseases caused by premature termination... ..., AP003, is a chemically modified, engineered tRNA oligonucleotide encapsulated in a...SeniorFull time- ...Product Manager This role provides the opportunity to build around established products... ...proven background in ground-up product development in software. Experience with... ...functional teams including marketing and engineering to bring products to market in a timely...Senior
Saviance
Boston, MA2 days ago - ...enhancements. Presents recommendations to key client decision makers. Resolves complex client issues related to products, services, or processes. Drives the development and implementation of potential solutions to meet client needs. Leverages experience and internal...SeniorWork experience placement
Vanguard
Boston, MA5 days ago - Job Opportunity Looking for someone with 10 years of experience, and coming from the financial services industry. This role is fully onsite at the One Congress office in Boston- relocation allowed but not preferred Must haves: Java Kafka Oracle ...SeniorWork at officeRelocation
Samprasoft
Boston, MA3 days ago - Join Esri's State And Local Government Account Team We invite you to bring your experience and passion for local government coupled with an understanding of applying geospatial technology to become an integral part of Esri's state and local government account team. ...SeniorLocal area
$204k - $348k
...Sr Principal/ Principal Software Engineer, AI Lab Execution System Cambridge, MA USA; San Francisco, CA USA Your Impact at LILA We are seeking... ...ML researchers, platform engineers, data engineers, product teams, and scientists to turn complex scientific processes...SeniorFull timeWork at officeLocal areaFlexible hoursLila Sciences
Cambridge, MA21 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Product Development Engineer. Be the first to apply!
Related searches
- process development scientist Boston, MA
- product development engineer Boston, MA
- r&d engineering technician Boston, MA
- r&d engineer Boston, MA
- product development scientist Boston, MA
- research and development engineer Boston, MA
- development engineer Boston, MA
- senior game producer Boston, MA
- senior electronic design engineer Boston, MA
- senior robotics software engineer Boston, MA