Single Use Development Engineer

Posted 04 Oct 2019

Bedford, Massachusetts - United States

Req Id 198431

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

We are seeking a Development Engineer to join the Novel Modalities franchise within MilliporeSigma. As a member of the Cell Therapy Bioprocessing group, you will collaborate with cross-functional teams developing complex disposables for automated cell therapy manufacturing systems. In this role, the candidate will act as a contributing member of a technical team in the development and validation of single-use products and their manufacturing processes. This position will be based at our Bedford, MA campus.  In this position, the following responsibilities will be expected:  Facilitates new consumable development for manufacturing of autologous cell therapies. Engages in all phases of new product development, including concept, architecture, documentation, design, prototype, test, supplier interfaces, and transfer to manufacturing.  Develops robust designs that can be produced cost-effectively and according to established project timelines.  Works from product specifications and requirements to develop component and assembly geometry, specify materials, and establish acceptable performance metrics.  Owns construction and testing of prototype disposables and pilot products, conducts analysis of test results.  Plans and executes DOE in conjunction with supporting data analysis.  Prepares mechanical drawings and assembly models complete with calculated dimensions and tolerances using 2D and 3D CAD.  Writes validation documentation for manufacturing processes.  Interfaces directly with manufacturing to clarify questions on drawings and designs.

 

Minimum Qualifications:

  • BS in Plastics, Mechanical, or Chemical Engineering
  • 5+ years of experience designing for the medical or pharmaceutical industry

 

Preferred Qualifications:

  • Knowledge of bioprocessing/cell therapy compatible materials
  • Experience with product design & proficiency with CAD software packages / techniques
  • Experience with thermoplastics is highly desirable
  • Good understanding of polymeric materials and manufacturing techniques, specifically injection molding, extrusion, heat bonding and ultrasonic bonding
  • Knowledge of manufacturing and process development activities such as qualification, validation, design of experiments, FMEA and design for manufacturing
  • Must be self-motivated, enthusiastic, and able to interact effectively with people in all areas of the company including Plant Operations, R&D, Quality, and Product Management
  • Familiarity with FDA and EMA requirements for pharmaceutical and medical devices
  • Experience working with CDMOs for research and manufacturing is desirable

 

RSRMS


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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