- Merck & Co. (Rahway, NJ)
- …activities with the clinical, regulatory, formulation, commercial and other key company functions. Lead the Device Engineering Sub-Teams focused on ... launch. The ideal candidate will possess extensive knowledge in medical device engineering , particularly in the design, manufacturing, verification, validation… more
- Merck & Co. (Rahway, NJ)
- …regulatory, company, and customer requirements.- -Principal ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead ... - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering , Biomedical ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to...PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering , with at… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- Merck & Co. (Durham, NC)
- …experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality , Technology, Engineering , Supply Chain, etc.).-At least ... Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability… more
- NY CREATES (Albany, NY)
- …purity, quality , and facility performance. In this role, the Lead Maintenance Technician will oversee all areas of responsibility. Key responsibilities include: ... innovation and commercialization. Job Description: JOB SUMMARY The TGCM Lead Maintenance Technician is responsible for maintaining, operating, and conducting… more
- Philips (Minneapolis, MN)
- Job Title R&D Project Manager - Medical Device (Plymouth, MN) Job Description R&D Project Manager - Medical Device (Plymouth, MN) Cross-functional Project ... Manager responsible for the development and launch of new medical device products supporting Philips Image Guided Therapy Devices business. Your role: Leading one to… more
- Medtronic (Boston, MA)
- …more connected, compassionate world. A Day in the Life of a Post-Market Risk, Quality Engineering Manager - reporting to Director of Post-Market Risk, Surgical ... *Significant breadth and depth in quality decision making, risk management, quality engineering , reliability engineering , and writing for compliance.… more
- BioSpace (Pleasanton, CA)
- …FDAs Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...(other duties may be assigned.): Act as a technical lead for product development projects. Provide mentoring and guidance… more
- Right Hire Consulting (Cambridge, MA)
- …manufacturers and stakeholders. Qualifications: Bachelors degree or higher in Mechanical Engineering . 5+ years of experience in medical device manufacturing, ... About the job Senior Manufacturing Engineer Medical Device The Senior Manufacturing Engineer plays a key role in bridging R&D, pilot, and commercial manufacturing… more
- Quest Diagnostics (Tucker, GA)
- Job Description Industrial Engineer / Lean - Lead - Tucker, GA - Monday - Friday 8:00AM-5:00PM The Industrial Engineer Lead plays a key role in the definition, ... of the Lab Operations frameworks. Responsible for the facilitation of industrial engineering principles - Lean across the organization, helping form and inform new… more
- Terumo BCT, Inc. (Littleton, CO)
- …investigations, this position is ideal for professionals with experience in medical device quality systems. If you're passionate about improving lives through ... you to be part of our mission-driven team. ESSENTIAL DUTIES Works with quality management, manufacturing, engineering , and other functional groups on regulatory… more
- SunCoke Energy (Lisle, IL)
- …SCE plan to leverage customer blast furnace operations and cost through improved product quality initiatives. Lead and develop plant Quality Managers to ... POSITION/JOB TITLE : Corporate Quality Manager DEPARTMENT : Commercial DIRECT SUPERVISOR :...blending and coking predictions. Ensure material contamination prevention and lead root cause investigations as needed Utilize SPC to… more
- GE HealthCare (Waukesha, WI)
- …to assure regulatory compliance (FDA, IEC 60601, etc.) Effectively communicate to Quality , Supply chain, and Engineering teams regarding application and use ... test protocols, FMEAs, V&V, etc.) to product engineers to address recurring quality /reliability failures is key. Creating and managing effective dashboards to show… more
- Michael Page (Concord, NH)
- …Engineer will be responsible for: Recommend improvements to machining processes to enhance quality and reduce costs. Apply engineering principles to develop and ... workflows. Investigate customer issues and support CAPA efforts to ensure resolution. Lead process improvements for both new and existing parts. Define tooling needs… more
- Boston Scientific (Maple Grove, MN)
- …impact Develops and maintains positive relationships with regulatory agency staff Lead and/or participate in regulatory audits, as required Required qualifications: ... advanced degree (Master's or PhD) in a relevant scientific or engineering discipline Demonstrated leadership, strategic thinking, project planning, and project… more
- Fisher Associates, PE, LS, LA, DPC (Davidson, NC)
- …seeking a Transportation Group Manager with deep expertise in transportation engineering and infrastructure project delivery to establish and grow our transportation ... full backing of a trusted, multi-disciplinary firm. In this high-impact role, you'll lead strategic planning, recruit and develop a local team, and manage the… more
- Abbott (Buffalo Grove, IL)
- …accessories). Third Party management of domestic and international sites for finished device manufacturing including yield and quality data reports, finished ... robust compliance and alignment with FDA, ISO, cGMP, etc Lead continuous improvement initiatives within the QMS framework. Manage...industry Minimum of 4-6 yrs of experience in a Quality role in Medical Device industry Substantial… more
