- Merck & Co. (Rahway, NJ)
- …launch. The ideal candidate will possess extensive knowledge in medical device engineering , particularly in the design, manufacturing, verification, validation ... clinical, regulatory, formulation, commercial and other key company functions.Lead the Device Engineering Sub-Teams focused on development of design requirements… more
- Merck & Co. (Rahway, NJ)
- …- Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and ... commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action.- The DD&T… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... Primary responsibilities include but are not limited to the following: Perform quality assurance activities related to API manufacturing in a complex, clinical… more
- Merck & Co. (Rahway, NJ)
- …control strategies, statistical analysis, and advanced statistical methods for medical device and combination product engineering within the pharmaceutical ... device and combination product regulations, manufacturing processes, and quality control.Proficiency in advanced statistical methods, such as partial least… more
- Merck & Co. (Rahway, NJ)
- …(PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Durham, NC)
- …experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality , Technology, Engineering , Supply Chain, etc.).-At least ... with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver… more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... 14+ years with a degree in Chemical / Biochemical Engineering , Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related… more
- Twist BioScience (South San Francisco, CA)
- …and able to succeed in a fast paced organization. A strong scientific or engineering background is a must.Job title and compensation will be determined based on ... team members through ISO 13485 design control process; creates and maintains a high- quality DHF.Builds high morale and team commitments to goals and objectives by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the ... Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global… more
- Cook Medical (Canton, IL)
- …engineering experience. Any engineering discipline if coming from a medical device background -OR- quality engineering experience from any regulated ... Overview The Manufacturing Quality Engineer serves as the lead quality...in assigned departments by partnering with Operations and Production Engineering and providing guidance on issues in line with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Coordinate risk mitigation activities across clinical, regulatory, quality , and engineering functions + Perform safety reviews on device and combination ... Serve as clinical liaison to Global Device Team, including engineering , regulatory affairs, quality , and commercial functions + Coordinate interdepartmental… more
- Stryker (Irvine, CA)
- …+ Bachelor's degree in Engineering or Technical field. + Prior medical device manufacturing and quality engineering experience. + Thorough knowledge of ... products while applying comprehensive knowledge of lean six sigma and quality engineering principles, six sigma black belt, design for manufacturability (DFM)… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and managing device engineers. + A Bachelor's Degree in Mechanical Engineering , Chemical Engineering , Biomedical Engineering , or a related scientific ... together. **Job Description** We are seeking a dynamic and people-focused Director of Device Development to lead a team of engineers in the design and delivery… more
- Kelly Services (Rochester, NY)
- …+ Minimum 4 years in medical device or pharmaceutical industry in Quality , R&D, Engineering or Laboratory environment + Familiarity with relevant regulations ... Engineering has an opportunity for a **Senior Quality Design Engineer** to work in **Rochester, NY** for...marketed product changes and updates (MOB) and represent design quality on new product development and/or device … more
- Gilead Sciences, Inc. (Foster City, CA)
- …goals, and results to team members across functions and departments, including device development, packaging, quality , regulatory affairs and manufacturing. + ... aspirations. Join Gilead and help create possible, together. **Job Description** The Device , Packaging, and Process (DPP) function is a key component of Gilead's… more
- Integra LifeSciences (Plainsboro, NJ)
- …into the Manufacturing Site. Participate in problem solving teams. Facilitate from a Quality Engineering & Quality Systems and Plant perspective the ... outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma**...and surveillance audits and customer audits. + Perform other Quality Assurance and Quality Engineering … more
- Stryker (Flower Mound, TX)
- …* Understand the product's intended use and clinical procedures Med Device Compliance: * Understand fundamental industry standards, design requirements and test ... which align with regulatory requirements * With supervision, create or refine engineering documentation, such as the Design History file per company design control… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in ... device risk management activities + You have a quality mind-set To be considered for this role you...role you must hold a Bachelor's degree in an Engineering subject area and the following amount of work… more
- Amazon (Monroe, OH)
- Description The Device Quality Manager (DQM) is responsible for ensuring that Amazon products are produced and packaged to meet or exceed our high bar for ... excellent customer experience. The DQM is responsible for the device quality during development of each project,...Mechatronics, or equivalent; * 7+ years working experience in engineering and quality role in a manufacturing… more
- Lilly (Indianapolis, IN)
- …for people around the world. The Associate Director- Quality - Indianapolis Device Manufacturing Device Quality Control Lab is primarily responsible ... for quality control oversight of the Device Quality Laboratory. **Responsibilities:** + Provide leadership...duties as required **Basic Requirements:** + Bachelor's degree in Engineering , Medical or Life Sciences + Minimum of five… more
