14 process controls engineer jobs found

Position Summary: We are looking for a highly technical Staff Systems Engineer who will play a key role in the design and development dialysis instruments at NxStage Medical. He or she will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment. This individual will lead systems engineering related activities on product development programs, exhibiting outstanding verbal and written communication skills. Core Responsibilities: Leads the development and maintenance of system architecture, product specifications, requirements documents, build instructions, acceptance test specifications, V&V documentation, and other technical documentation. Provides technical leadership for product development, integration, testing, and reliability improvements. Leads modeling-based design and development and systems engineering activities. Work with experts across Fresenius Medical Care to integrate new tools into design and development...

Job Title: Senior Manufacturing Equipment Engineer FLSA Status: Exempt Company Overview Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it. Position Overview The Senior...

Job Description Are you ready to revolutionize Cell & Gene Therapy? Join us in shaping the future of therapeutics! We are seeking a Senior Mechanical & Automation Engineer in our journey of developing cutting-edge manufacturing solutions for Casgevy-a first-of-its-kind therapy transforming the treatment of Sick Cell Disease and Beta Thalassemia. In this role, you will be at the forefront of automating complex processes in one of the most dynamic and rapidly evolving fields in biotechnology. By leveraging your expertise in mechanical engineering and automation, you will play a pivotal role in streamlining manufacturing, enhancing manufacturing reliability, and scaling life-saving therapies to reach patients faster. You will work with a passionate team of scientists, engineers, and innovators, all united by a shared mission: to push the boundaries of what's possible in Cell & Gene Therapy. This role reports to the Associate Director of Automation, Equipment, and...

Position Overview: The Plant Manufacturing Engineer is a critical member of the plant engineering and operations teams. This role is responsible for reliability engineering, monitoring, and standardizing the manufacturing process, anticipating and resolving bottlenecks to capacity, driving uniformity of maintenance and operations principles, identifying and implementing cost and waste reductions, and general continuous improvement of the site. The successful candidate will have strong structured problem-solving skills of complex component and machine interactions and be comfortable working hands-on with automation machinery. Responsibilities: Accountable to driving maintenance process improvements in support of Insulet's primary manufacturing objectives: Best Quality, Best Service, Best Cost. Autonomously interprets data to drive plant decision making and prioritization of reliability efforts. Plan, execute, and manage efficiency improvement projects. Develop and...

Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise. We are currently seeking Engineering candidates to add to our growing team. RESPONSIBILITIES Partner with colleagues and leadership to enhance and refine injection molded and assembled products, as well as the processing across multiple manufacturing stages. Create and roll out validation protocols (IQ/OQ/PQ) aligned with FDA requirements. Lead troubleshooting efforts and guide the team through detailed root cause analyses. Apply Lean methodologies to...

Job Description: POSITION SUMMARY TransMedics is transforming organ transplantation through the Organ Care System (OCS), a breakthrough platform that preserves and assesses donor organs outside the body. Our Manufacturing Engineering team plays a critical role in ensuring safe, efficient, and scalable production of both disposable and capital equipment systems. The Manufacturing Engineering Intern will support production-related engineering activities associated with the manufacturing of the TransMedics Organ Care System. This role provides hands-on exposure to assembly processes, test systems, documentation control, and process validation within a regulated medical device environment. The intern will work closely with Manufacturing Engineers and be paired with a dedicated mentor to ensure meaningful project ownership and professional development throughout the program. RESPONSIBILITIES: This position is responsible for, but not limited to, the following: Manufacturing...

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...

Compensation: Salary Range depending on experience and qualifications. Role Overview Arrotek USA is seeking an experienced Sr Catheter Engineer specializing in catheter and guidewire design and process development. In this pivotal role, you will support the design, development, and commercialization of advanced interventional medical devices. This position is part of a rapidly growing Design Services organization and requires a hands-on engineer with strong technical depth, problem-solving ability, and client-facing communication skills. You will be involved in every stage of the medical device lifecycle - from concept development and prototyping to process development, verification/validation, and design transfer. Collaboration with cross-functional teams and external clients in a fast-paced, fee-for-service environment is central to this role. Key Responsibilities Design and develop innovative catheter and guidewire technologies, including concept generation,...

Associate Systems Engineer Job Description: Position Summary The Associate Systems Engineer position is designed to provide the selected candidate with a broad exposure to the design and development process for wearable medical devices that are used by patients around the world on a daily basis. This position will be an integral member of the R&D team directly supporting the product development phases of Insulet's innovation pipeline of wearable pump technology. This role will provide exposure to several aspects of Insulet's design control processes including but not limited to writing and interpreting product requirements, device integration, verification test methods, troubleshooting/design analysis, and design documentation. Responsibilities Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement. Support all phases of the design and development lifecycle of a medical device Participate in product design or technical...

Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky's the limit. Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and have the ability to make a profound impact on our business. The Manufacturing Engineer II will have responsibility to support the day-to-day operation of automated production equipment at RMB, Lowell. This...

Injection Molding Engineer Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise. We are currently seeking Engineering candidates to add to our growing team. DUTIES Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps. Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations. Provide troubleshooting focus and direction for the team with details of root cause analysis....

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...

Job Description Hologic's Breast & Skeletal Health division is seeking a Lead Electrical Engineer, NPD to drive the design and development of electrical systems for our next-generation imaging platforms. In this role, you'll be a senior technical leader, owning architecture and design for complex medical devices that directly impact patient care. What You'll Do Lead the design, development, and testing of electrical and electronic systems and subsystems for medical imaging products. Own electrical architectures and specifications, ensuring designs meet safety, quality, and regulatory requirements. Design and guide development of PCBs, power electronics, motors (BLDC/Stepper), feedback and protection circuitry, and cable/harness assemblies. Develop schematics (Cadstar/OrCAD) and work with PCB layout tools (Cadstar, PADS, OrCAD Allegro, Altium). Analyze and optimize image chain and system performance, driving design, cost, and time-to-market improvements. Build...

Job Description: POSITION SUMMARY The Director of Electrical & Systems Engineering will plan, design, and oversee the electrical and biomedical infrastructure of our organization to ensure those designs are implemented effectively while meeting the needs of the business and adhering to industry standards. This role also involves leading and mentoring a team of electrical and biomedical engineers, developing long-range plans, strategies, and driving top-level company objectives. This position is onsite 5 days a week. RESPONSIBILITIES Responsible for the electrical architecture, design and testing for the Next Generation Organ Care System while ensuring compliance with project requirements and regulatory standards. Provide leadership, oversight and guidance to internal and external design teams for new and legacy products, complaint investigations, and obsolescence. Possess a hands-on approach to developing electrical engineering strategies, prototypes and designs for...