Senior Process Engineer

2 days ago

Elkton, Maryland, United States Terumo Full time
Job Summary

The Sr. Engineer I - Process Engineering position is a key role in the development and implementation of new manufacturing processes for global medical devices. As a member of the Process Engineering team, you will be responsible for providing advanced engineering support to existing product process transfer projects, process improvements/cost reduction activities, and new product development process and production equipment development requirements.

Key Responsibilities
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Participate in and contribute to project team meetings, Design Reviews and other formal project reviews.
  • Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition.
  • 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.
Requirements
  • 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.
Qualifications/Background Experiences

BS 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.

Terumo is an equal opportunity employer and welcomes applications from diverse candidates. 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.

  • Process Engineer

    2 days ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job SummaryThe Process Engineer II position is a mid-level engineering role responsible for providing 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...

  • Senior Propulsion Engineer

    4 weeks ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...

  • Senior Propulsion Engineer

    3 weeks ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...

  • Senior Propulsion Engineer

    3 weeks ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...

  • Senior Propulsion Engineer

    4 weeks ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...

  • Chemical Process Engineer

    4 weeks ago

    Elkton, Maryland, United States eTeam Full time

    Job Title: Chemical EngineerWe are seeking a highly skilled Chemical Engineer to join our team at eTeam. As a key member of our Process Development team, you will play a critical role in the development and optimization of our bioprocesses.Key Responsibilities:Participate in the development and execution of fermentation and purification processes at lab and...

  • Industrial Engineer

    1 month ago

    Elkton, Maryland, United States Autokiniton Full time

    Job SummaryAutokiniton is seeking an experienced Industrial Engineer to join our team. As an Industrial Engineer, you will be responsible for providing technical leadership and expertise to optimize our manufacturing processes, improve efficiency, and enhance quality.Key ResponsibilitiesDevelop and implement process improvements to increase productivity and...

  • Senior Tooling Engineering Manager

    3 hours ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job SummaryNorthrop Grumman is seeking a Senior Tooling Engineering Manager to lead a team of tooling engineers in support of PS&C programs. The successful candidate will have a strong background in engineering and design, with experience in leading teams and managing budgets.The ideal candidate will have a bachelor's degree in engineering and 10 years of...

  • Senior Quality Systems Engineer

    4 weeks ago

    Elkton, Maryland, United States Terumo Full time

    Job Summary:The Senior Quality Systems Engineer will play a critical role in ensuring compliance with global Quality System regulations, including 21 CFR Part 820 and ISO 13485:2016. This position will drive the management and effectiveness of the Quality Management System, primarily the CAPA system.Key Responsibilities:Provide guidance to CAPA Teams and...

  • Senior Quality Systems Engineer

    2 weeks ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job SummaryThe Senior Quality Systems Engineer will drive Terumo Medical Corporation's efforts to ensure compliance with applicable global Quality System regulations in an efficient manner.Key ResponsibilitiesSupport the management and effectiveness of the Quality Management System, primarily the CAPA system by:Providing guidance to CAPA TeamsParticipating...

  • Manufacturing Engineer

    2 days ago

    Elkton, Maryland, United States Terumo Full time

    Job SummaryThe Senior Engineer 1 - Manufacturing Engineer position is responsible for ensuring the successful day-to-day operation and continuous improvement of a dedicated endovascular medical device manufacturing process within the Terumo Medical Corporation (TMC) Elkton, MD facility.Key ResponsibilitiesProvide manufacturing engineering expertise in the...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Elkton, Maryland, United States Actalent Full time

    Job Title:Sr Complaints Quality EngineerJob Description:The Sr Complaints Quality Engineer will provide engineering support in post-market surveillance, with a focus on complaint investigations, product evaluations, root cause and complaint trend analysis.The associate is responsible for planning and coordinating the daily complaint engineering activities...

  • Manufacturing Process Specialist

    4 weeks ago

    Elkton, Maryland, United States AllSTEM Connections Full time

    Entry Level Manufacturing Process Engineer I (Assistant)We are seeking a highly skilled and motivated Entry Level Manufacturing Process Engineer I (Assistant) to join our Technical Operations team in a dynamic and collaborative environment. As a key member of our team, you will play a critical role in supporting sterile manufacturing processes by providing...

  • Senior Full-Stack Developer

    4 weeks ago

    Elkton, Maryland, United States Aurora Ventures Full time

    About Aurora VenturesAurora Ventures is a pioneering company that specializes in creating cutting-edge digital media products. Our team is passionate about pushing the boundaries of innovation and delivering high-quality solutions that meet the evolving needs of our clients.Job DescriptionWe are seeking a highly skilled Senior Full-Stack Engineer to join our...

  • Senior Medical Device Complaints Manager

    2 weeks ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job SummaryThe Senior Manager, Medical Device Product Complaints is responsible for overseeing medical device complaints in accordance with applicable global regulations. This includes directing personnel and maintaining all activities associated with customer complaints, working closely with the Customer Service and Field Clinical groups to process all...

  • Manufacturing Engineering Manager

    4 weeks ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job SummaryThis leadership position is responsible for planning, directing, and implementing projects to enhance manufacturing processes for existing products or the development of new products that directly impact safety, quality, and productivity, resulting in the production of a better-quality product more efficiently.Key ResponsibilitiesDirect and...

  • Electrical Engineer

    3 weeks ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Electrical Engineer - ControlsWe are seeking an experienced Electrical Engineer - Controls to join our team at Northrop Grumman's Elkton, Maryland facility. This position will be at the Engineer (level 2) or Principal Engineer (level 3) level.Job Summary:The successful candidate will be responsible for coordinating efforts to modernize industrial...

  • Propulsion Engineering Manager

    4 weeks ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job DescriptionWe are seeking a highly skilled Propulsion Engineering Manager to join our team at Northrop Grumman. As a key member of our Motion Controls Engineering group, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane.Key ResponsibilitiesDeveloping and executing a technical roadmap to identify...

  • Propulsion Engineering Manager

    3 weeks ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job DescriptionNorthrop Grumman is seeking a highly skilled Propulsion Engineering Manager to join our team in Elkton, Maryland. As a key member of our Motion Controls Engineering group, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building relationships with potential and existing...

  • Propulsion Engineering Manager

    2 days ago

    Elkton, Maryland, United States Northrop Grumman Full time

    Job DescriptionNorthrop Grumman is seeking a highly skilled Propulsion Engineering Manager to join our team in Elkton, Maryland. As a key member of our Motion Controls Engineering group, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building relationships with potential and existing...