11 senior test engineer jobs found

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...

Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come. TITLE: Senior NPI Process Development Engineer POSITION SUMMARY: The Senior NPI Process Development Engineer will focus on further developing our product and then transferring it into a manufacturing setting. The successful candidate will possess a passion for medical device engineering and a record of successful process, tooling and equipment design. This role will engage in cross-functional collaboration to accelerate the product development process, reduce cost of goods, and enable more complex designs through manufacturing...

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Job Summary We are seeking an experienced and creative-thinking Senior Biomedical Product Development Engineer to join our multidisciplinary Research & Development Systems Engineering team in Boston, MA. In this role, you will serve as the primary owner of the mechanical design and functional performance of disposable components used within the TEG6s in vitro diagnostic (IVD) system. You will play a critical role across the full product lifecycle-supporting both new product development and sustaining engineering initiatives-while collaborating closely with assay development, manufacturing, quality, regulatory, system hardware, clinical, and commercial teams to ensure robust product performance and successful market introduction. Your work will...

Sun Pharma is the world's fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Job Summary: This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects. Area Of Responsibility: Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements Prepare and maintain all necessary product...

Why Orthofix? Guided by our organizational values - Take Ownership | Innovate Boldly | Win Together - we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further. How you'll make a difference? The Senior Design Engineer is responsible for assisting in the development of new medical device systems from concept to market introduction in accordance with FDA and ISO requirements. The Senior Design Engineer will also collaborate with other engineers...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Integrated DNA Technologies (IDT), one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At...

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 Staff Engineer, Design is primarily responsible for designing and developing new production equipment and tooling to support manufacturing needs, including cost reduction, ergonomic improvements, quality enhancements, and new product introductions. Following equipment deployment, the engineer supports validation activities and assists maintenance/manufacturing teams when validation or maintenance findings require design modifications. This role ensures that equipment designs are robust, well-documented, and compliant with applicable medical device...

Job Type Full-time Description Job Summary The Senior Process Development Engineer - Delivery Systems works cross-functionally to develop and refine manufacturing processes for complex catheter-based delivery systems, including reinforced catheters, balloon catheters, steerable catheters, multi-lumen, and multi-durometer shafts. This role focuses on post-design-freeze activities such as tooling, fixture development, process characterization, and validation (IQ/OQ/PQ), ensuring robust and scalable production for high-performance medical devices. The engineer will serve as a technical subject matter expert on customer and internal project teams, driving process innovation and execution through collaboration with cross-functional partners in Quality, Operations, and Program Management. Essential Functions Works independently to develop, optimize, and validate manufacturing processes for catheter-based delivery systems including reflow, bonding, molding, of reinforced shaft...

Job Description: POSITION SUMMARY: The Principal Engineer - NPI Manufacturing serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of TransMedics perfusion set and OCS products. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables. Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes. Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards. Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for...

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 Provide Engineering/Manufacturing technical expertise in support of the total operations functions, goals, objectives, and projects of the STERIS Endoscopy division of STERIS. Responsible for establishing and maintaining manufacturing processes and procedures, including capacity planning, tooling, process development, routings, cost reductions, and quality improvements. Helps give technical expertise to Engineering teams through mentorship, acting as a reviewer, and aiding in the guidance of strategic initiatives. Some travel is required, estimated at 2 or 3 weeks per year. What You'll Do as a Advanced Process Manufacturing Engineer Support all Company Quality Policies including ISO 13485, MDD, and FDA. Develops methods, standards, procedures, plans, processes, programs, and schedules to...

Job Type Full-time Description SHINE Technologies is seeking a Mechanical Engineer who will focus on mechanical systems in the Auxiliary Systems engineering group. This position will encompass ownership of demineralized water, nitrogen gas handling, compressed oxygen, and nitrogen purge gas systems. Key responsibilities associated with system ownership include vendor oversight for procurement, reviewing and approving design or fabrication documents, coordination with Construction during installation, site walkdowns, and inspections. The base salary range for this position is $76,100-$130,500 annually plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location. Duties and Responsibilities: Examples of specific duties and responsibilities for the Mechanical Engineer role include, but are not limited to: Interfacing with Project Controls team on scheduled tasks and provide updates on a weekly basis for reporting purposes Preparing...