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Engineer, Sr Process Job

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Date: Nov 10, 2021

Location: Marlborough, United States, 01752

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

 

Position Summary:


Works cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer into production. This job requires 30% travel commitment. May also require a 3-6 month assignment at another BSC site.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

 

Position Responsibilities:

 

  • Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
  • Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
  • Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
  • Plans, organizes, and conducts all aspects of technical reviews.
  • Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
  • Writes and reviews validation protocols and reports applicable to new processes.
  • Oversees development builds associated with the project using special work requests.
  • Develops qualified production lines.
  • Provides Design for Manufacturability (DFM) input to the engineering print package.
  • Contributes ideas to or generates Intellectual Property submissions.
  • Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
  • May serve as a core team member or extended team member on new product projects.
  • Ensures that all aspedts of the quality system are the first priority in all activities (e.g., validation protocols, quality plan development, FMES'a and DCM's).
  • Improves the quality of patient care and all things Boston Scientific.
  • Develop and document processes, methods, tooling and production controls for new programs.
  • Design for manufacture, process optimiization (ranging studies) and validation.  Technology transfer into manufacturing.
  • Manage all phases of equipment qualifications and process validations (protocols, data analysis, reports).
  • Conduct test method validations (Gage R&R).


Required Qualifications:

 

  • BS in Mechanical Engineering or other related technical degree plus a minimum of 5 years of process engineering, manufacturing engineering, product development or other related experience is required. Prior experience with the assembly of medical devices (implant and/or disposables) is preferred.  A Master of Science with a minimum of 3 years or Ph.D. with a minimum of one year experience.
  • Experience in leading new product process development and process validation in an FDA or other regulated manufacturing environment is required.
  • Experience with the introduction and commercial scale-up of new disposable medical products is preferred.
  • Must have experience performing various types of statistical analysis and be able to demonstrate expertise and leadership in the use of statistical experimental design and analysis techniques. Design of Experiments (DOE) or equivalent analysis technique is preferred.
  • Must be able to demonstrate competency in leading others in critical thinking, problem solving and analysis and effective technical discussion.


Preferred Qualifications:

 

  • Medical device company experience working in process or manufacturing engineering.
  • Work experience in performing Design of Experiments and writing engineering protocols and reports.
  • Excellent technical writing and engineering documentation skills.
  • Excellent organizational, communication and collaboration skills.
     

 

Requisition ID: 511446

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


Job Segment: Process Engineer, Manufacturing Engineer, Engineer, Medical, R&D Engineer, Engineering, Healthcare