29 specification writer 2 jobs found

Job Title: Associate Manufacturing Engineer (On-site) Department: 003824 - China Sustaining Engineering FLSA Status: Exempt Position Overview: The Associate Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet's manufacturing base across the world, at Contract Manufacturer (CM) sites and at Insulet's US Manufacturing facility in Acton, MA. The candidate will be based out of Insulet HQ in Acton, MA, but will be expected to travel frequently to manufacturing sites as required to complete project deliverables. This candidate will be work both on the addition of new manufacturing lines and equipment, as well as continuous improvement efforts for existing manufacturing processes/equipment. The candidate will use his/her knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful...

Job Description Support and lead the development of medical device products, including writing or verifying specifications; maintaining product process; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts and/or prototypes meet their requirements. Develop new product concepts and products by applying various engineering disciplines, such as mechanical, electrical, materials, bioengineering, or other relevant fields Provide engineering design and process development, and/or sustain engineering support Develop products or processes, or the capabilities to support them, such as test methods, equipment/fixtures, data engineering, statistics, software coding and application, engineering/business intelligence, or various analytical methods, etc. Generate intellectual property; write invention disclosures Specify and/or direct the specification and testing of new materials and designs Confer with appropriate departments, resources,...

Job Description: Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships POSITION SUMMARY We are seeking a results-driven Senior Test Engineer with experience in the medical device industry to join our test engineering team. This role is responsible for developing, executing, and overseeing the testing strategies that ensure the safety, reliability, and compliance of Class II/III medical devices in accordance with FDA and ISO 13485 regulations. The ideal candidate has a deep understanding of medical device lifecycle processes and a strong technical background in test systems, automation, and compliance in regulated environments. This position is based at our Andover, MA headquarters. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Lead test engineering activities for new development projects. Responsible for conducting feasibility and...

Holland Applied Technologies, located in Burr Ridge, is a leader in the sanitary process/equipment industry. We fabricate and distribute sanitary equipment and systems for the food, pharmaceutical, personal care, and beverage industries. We are seeking a Design Engineer (Electrical) to join our team! The Engineer will research, design, develop, and/or test electrical systems for the variety of products we manufacture. Job Responsibilities: Designs and develops electrical systems used in the automation of industrial tasks Reads and interprets customer specifications Develops electrical system overview drawings Develops panel layout drawings Develops wiring schematics for 1 phase and 3 phase AC and DC circuits Develops loop and bus diagram drawings Develops pneumatic diagrams Assists in conduit design and panel location Size wiring, fuses, components, panels, etc. Completes panel heat calculations Provides direction during fabrication Estimates material and labor...

Job Description Responsible for supporting process development and improvements for medical devices for both existing and new product development, production, and processes. This includes working closely with R&D at the early phases of product development to create manufacturing specifications, maintain, and enhance product processes, and design fixtures and equipment, testing processes, equipment, and validate test methods, and select raw materials to ensure that the concepts and prototypes meet their specifications. Support projects related to new product introductions, existing process improvement and engineering to improve product quality and yields, and other engineering tasks. Evaluate, initiate, and establish improved engineering and project systems for procurement and execution of process validation. Work with Manufacturing, Quality, Regulatory, and global Marketing teams internally and outside vendors and consultants. Develop new processes and perform process...

Job Description This 18-month rotational program is designed to train new Engineers on various aspects of Terumo Neuro technology, procedures, and processes. All candidates will be assigned a Mentor, Peer Mentor, as well as an Advisor to oversee their program succession, and will be provided with additional classroom training. Successful candidates will have three (3) six-month rotations. These rotations include one (1) required rotation in Manufacturing Engineering and two (2) optional rotations from the following areas: Research & Development (R&D) Equipment/Tool Design Marketing Regulatory Affairs Quality Supply Chain Job duties: Support development of medical device products with work including writing or verifying specifications, designing new products, fixtures, test processes, equipment and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Typical job duties might include: Developing new product concepts and...

Position Overview The Associate Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet's manufacturing base across the world, at Contract Manufacturer (CM) sites and at Insulet's US Manufacturing facility in Acton, MA. The candidate will use his/her knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new manufacturing equipment and processes. The person will be responsible for KPIs for project budget and timing, as well as machine up-time, process yield and efficiency once equipment is in production. As part of providing support to the Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work...

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: We are seeking a Principal Delivery System Engineer to play a key role on...

Job Description Support and lead teams in the development of medical device products, including writing or verifying specifications; maintaining product process; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts and/or prototypes meet their requirements. Job duties: Develop new product concepts and products. Provide engineering design and process development. Generate intellectual property; write invention disclosures. Supervise technicians, specialists, and associate engineers. Specify and/or direct the specification and testing of new materials and designs. Confer with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems, and develop designs. Largely self-directed and capable of meeting project goals with minimal supervision. Perform additional responsibilities as assigned. Qualifications Bachelor's degree in Mechanical Engineering, Industrial Engineering,...

Description Who We Are BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients.. About Technical Operations Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain...

The Utilities Engineer is responsible for oversight of design, engineering, safety, and quality support in the following utility equipment systems: Clean Steam, Purified Water, WFI and RO Systems, HVAC Systems, Plant Steam Systems, Co-Generation Units, Process Chillers, Compressed/Process Air, Nitrogen, Ammonia Chillers and Refrigeration Process, Alcohol Distillation and Recovery Process, Process Gases, Natural Gas, Bulk Chemical Distribution, Solvent Gas Detection systems, Fire Alarm, Control and Protection Systems, Electrical Systems, Water, Cooling towers and Waste Treatment systems for the Kankakee facility. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Role that this position reports to: Sr. Manager, Utilities Engineering Positions reporting into this role: N/A Main Responsibilities and Accountabilities: 1. Technical lead accountable for the operational improvement of the utility systems based upon...

Job Description Support development of products and/or product engineering for medical device with work including writing or verifying specifications; designing new products and fixtures; testing processes and equipment; and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. 1. Develop new product concepts and products by applying various engineering disciplines, such as mechanical, electrical, materials, bioengineering, or other relevant fields 2. Provide engineering design and process development, and/or sustain engineering support 3. Develop products or processes, or the capabilities to support them, such as test methods, equipment/fixtures, data engineering, statistics, software coding and application, engineering/business intelligence, or various analytical methods, etc. 4. Generate intellectual property; write invention disclosures 5. Largely self-directed and capable of meeting project goals with minimal supervision 6. Lead projects...

Job Description Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer launch, and post market phases. Work closely with R&D counterparts, Operations, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch and continue supporting product sustainment. Job Duties: 1. Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs 2. Ability to translate abstract ideas into design solutions using variety of methods including but not limited to simple hand sketches, 3D...

Job Description JOB TITLE : Package Engineering Senior Manager LOCATION : 50 Northern Ave., Boston, Massachusetts, 02210 OPENINGS: 1 DUTIES: Represent department on cross-functional CMC sub-teams, with minimal guidance. Ensure positive and effective relationships with key suppliers of materials, technology, and manufacturing resources. Manage and design key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection, testing, and sourcing. Work effectively with multiple stakeholders including Pharmaceutical Sciences, Manufacturing Sciences & Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, Marketing and other cross functional departments to meet project timelines and objectives. Review process performance to identify continuous improvement activities for commercial products. Lead technical transfer and process validation...

Make renewable energy better-every day. Join a mission-driven engineering team that designs, improves, and scales corn-based ethanol technologies that sustain agriculture, advance renewable energy, and expand global protein supply. Our technologies operate across a broad footprint of biorefineries, and our culture champions Collaboration, Humility, Ownership, Innovation, and Stewardship. Design choices matter. In this role you'll help cut energy intensity, improve yields, and reduce waste streams across biorefineries-moving the needle on decarbonization while sustaining agricultural economies. Our mission centers renewable fuels and responsible innovation; your engineering rigor turns that mission into measurable plant-level outcomes. You will assist with troubleshooting issues at operating plants and develop solutions that are timely and cost effective. Provide solutions that may include design packages with equipment specifications and P&ID updates to reflect changes. Assist...

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Research and Development Intern supports the Research and Development Engineering team. The student will receive an introduction to medical device design, product development, and design change processes. This includes computer-aided design, testing, manufacturing, fabricating prototypes, designing test fixtures, and operating test equipment. A key objective will be an introduction to robust design and the product development process of cardiac surgery devices. Job Responsibilities and Essential Duties The primary "essential" duties and...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities....

Job Description General/Position Summary: The Director, Facilities Engineering is a pivotal role within Global Operations & Real Estate department, with a wide range of responsibilities for the company's real estate portfolio, which consists of research and development, GMP manufacturing, office, and other types of facilities. The role oversees and manages the Project Engineering, GMP Site Engineering, Advanced Manufacturing Engineering, and Engineering Documentation teams ensuring effective leadership, performance management, and alignment with organizational goals. The Facilities Engineering group works very closely with all levels of the Capital Project Management Office (PMO), Facilities & Operations, and various GMP manufacturing teams. The Director leads the development and implementation of company-wide engineering management processes, establishes facility design guidelines, policies, and standard operating procedures, spearheads energy resource reduction...

Job Description Support development of medical device products with work including writing or verifying specifications; designing new products and fixtures; testing processes and equipment; and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Job Duties: 1. Develop new product concepts and products 2. Provide engineering design and process development 3. Generate intellectual property; write invention disclosures 4. Supervise Assemblers, Technicians, and Specialists 5. Largely self-directed and capable of meeting project goals with moderate supervision 6. Some travel required 7. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization 8. Perform additional duties as assigned Qualifications 1. Bachelor's degree in Engineering or Scientific field 2. Minimum of two (2) years of...

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary Propose, oversee and improve the processes necessary to produce products ensuring safety first per all appropriate specifications at a rate considerate of company and customer targets. Lead problem solving efforts or continuous improvement projects to reduce waste and increase overall equipment effectiveness. Identify, propose, justify and manage the implementation of capital improvement projects or other improvement efforts. Participate and/or lead problem solving teams and initiatives to achieve Safety, Quality, Delivery and Cost metrics. What You'll do as a Process Engineer Identify, justify, propose and oversee the implementation of manufacturing equipment, technologies or processes to support defined targets for safety, quality, delivery and cost. Propose, support and participate in...