Senior process engineer job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

The Sr Engineer I - Process Engineering position is responsible for providing advanced engineering support to existing product process transfer projects, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment development requirements in accordance within all TMC processes and procedures.
Job Details:

Provide engineering support to the design, development, and qualification of products, processes, and process equipment in accordance with TMC QA101 Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control, and design control requirements.
2. Participate in and provide manufacturability insight and guidance to the design and development of new products to facilitate the development of viable production processes for the products under development.
3. Serve as a Process Leader for the development or transfer of production processes. Accountable for the execution of all engineering activities required to develop, implement, and validate processes under development or modification. The Process Leader “owns”” the big picture of the production process and ensures that its overall performance and validation requirements are achieved.
4. Actively lead and participate in the performance of formal process validations to ensure their compliance to validation protocols. Ensure all protocols and validation reports are correct and well-written.
5. Install production/process equipment and support the conduct of Installation Qualification (IQ), Operational Qualification (OQ), pre-Process Qualification (PQ), and formal PQ validation activities and the documentation of their results.
6. As required, serve as a Problem Solver to product and process issues and apply the proper engineering tools and techniques for their resolution and implementation of any required process modifications.
7. Participate in and contribute to project team meetings, Design Reviews and other formal project reviews.
8. Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition.
9. Prepare and present technical presentations to all levels of personnel in a manner that effectively communicates technical activities in an understandable way to the target audience.
10.Performs other job related duties assigned.
Knowledge, Skills, Abilities Experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements.Experience in the application of Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools. Demonstrated understanding of the cross-functional interactions needed for the development of new products and manufacturing processes, preferably within FDA design control guidelines.Demonstrated strong analytical and problem solving skills; ability to solve complex problems and implement solutions or processes.Demonstrated ability in the design, development and implementation through production qualification of a new or novel medical device production process.Strong communications skills. Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to the FDA. Effective use of MS Office Suite.
Background, ExperienceBS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college with 7 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field.
It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Role purpose

Perform process evaluations in response to challenges or opportunities faced by the business. Must develop innovative solutions to improve the safety, efficiency, or expand the capacity of an existing process or lead the process design effort on a new active ingredient or formulation.

Provide front end process designs, process descriptions/scope definitions, equipment specifications, and other process data necessary to enable detailed project design. Drive process design solutions and ensure safe, economical and reliable operation of the completed plant.

Provide innovative and cost-effective design solutions through networking and optimal use of internal and external resources and vendors.

Accountabilities

Indirect management of numerous design team, contractor personnel and commissioning team.

Perform process evaluations in response to challenges or opportunities faced by the business including Health/Safety/Environmental (HSE), efficiency, expansion, and sustenance type projects. Incumbent will provide mass and energy balances, physical properties calculations, process simulations, unit operations design and scale-up for new and improved chemical and/or formulation processes, evaluation of candidate processes/routes, and general chemical / formulation plant process design.

Provide front end process designs to enable detailed project design. Assist the project team in identifying process risks, scale-up concerns and uncertainty in the process area.

Provide functional design activities for equipment sizing/design, construction support, and facility commissioning.

Perform initial or revalidation Pressure Safety Valve (PSV) evaluation and sizing including identification of applicable sizing cases and the controlling case.

Provide Process Risk Assessment (PRA) assistance for the NAFTA region as needed to support capital projects in the region. Resolve process questions during hazard studies, detailed mechanical design, and start-up of new or modified plants.

Provide innovative and cost-effective alternate design solutions through networking and optimal use of internal and external resources and vendors.

Participate in cross-functional project teams to address HSE and process safety, and other regulatory requirements. As applicable, act as an interface with design firms or other agencies to promote best practices.

Lead cross functional teams to support site initiatives and engineering tactics related to process engineering.

Relocation will be offered for the right candidates.

At this time we are unable to provide Visa Sponsorship for this position.

Senior Process Integration Engineer-

At BAE Systems we make the worlds' lowest noise CMOS image sensors. These CMOS Image sensors enable our customers to see in the most extreme conditions.

As a Senior Process Integration Engineer at BAE Systems and a member of our technical R&D team, you will be the primary technical interface with silicon foundry partner, manage new device tape out, and drive wafer yield and process control.

As part of our drive to be the best in the world at low light imaging your role will be to develop, lead and execute yield and process improvement plans for CMOS Image sensor products to gain deep insight into process impact on product performance and yield.

Because this role involves a combination of collaborative/in-person and independent work, it will take the form of a hybrid work format, with time split between working onsite and remotely.

Required Education, Experience, & Skills

• Bachelor of Science in physics or electrical engineering or demonstrated equivalent.
• Detailed knowledge of semiconductor process technology and CMOS image sensor operation.
• Ability to develop and execute Design of Experiment to study process change impacts on product yield and performance.
• Ability to direct test and characterization activities required to determine the outcome of each DOE.
• Ability to generate detailed reports to influence key decision makers to change or modify the silicon process.
• Ability to clearly communicate requirements and expectations in a cross functional environment.

Preferred Education, Experience, & Skills

• MS in physics or electrical engineering. 5 years experience with CMOS Image Sensor wafer fabrication process.
• Experience with CCD a plus.

About BAE Systems Electronic Systems
BAE Systems, Inc. is the U.S. subsidiary of BAE Systems plc, an international defense, aerospace and security company which delivers a full range of products and services for air, land and naval forces, as well as advanced electronics, security, information technology solutions and customer support services. Improving the future and protecting lives is an ambitious mission, but it's what we do at BAE Systems. Working here means using your passion and ingenuity where it counts - defending national security with breakthrough technology, superior products, and intelligence solutions. As you develop the latest technology and defend national security, you will continually hone your skills on a team-making a big impact on a global scale. At BAE Systems, you'll find a rewarding career that truly makes a difference. Electronic Systems (ES) is the global innovator behind BAE Systems' game-changing defense and commercial electronics. Exploiting every electron, we push the limits of what is possible, giving our customers the edge and our employees opportunities to change the world. Our products and capabilities can be found everywhere - from the depths of the ocean to the far reaches of space. At our core are more than 14,000 highly talented Electronic Systems employees with the brightest minds in the industry, we make an impact - for our customers and the communities we serve.

Our Commitment to Diversity, Equity, and Inclusion:
At BAE Systems, we work hard every day to nurture an inclusive culture where employees are valued and feel like they belong. We are conscious of the need for all employees to see themselves reflected at every level of the company and know that in order to unlock the full potential of our workforce, everyone must feel confident being their best, most sincere self and be equipped to thrive. We provide impactful professional development experiences to our employees and invest in social impact partnerships to uplift communities and drive purposeful change. Here you will find significant opportunities to do meaningful work in an environment intentionally designed to be one where you will learn, grow and belong.