Principal Process Engineer

Alere   •  

Scarborough, ME

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 86 days ago

This job is no longer available.


The Principal R&D Process Engineer manages a wide variety of technical tasks and projects in the development of new products and manufacturing processes. This individual will be a technical leader within the R&D team and a key member of the medical device product development teams.

· Contribute directly to the development of new product concepts, processes, and techniques to ensure that products meet customer’s needs and are high quality and low cost.
· Serve as a technical interface within Alere between the Manufacturing and Materials, R&D, Quality, Regulatory, and Marketing organizations.
· Manage/hands-on design and development of new products and processes as well as product changes and enhancements. S/he will demonstrate knowledge to chemistry, plastics, molded and machine part design as per program requirements.
· Work closely with external partners to transfer new materials and mechanical products to manufacturing. This person will plan, schedule and complete the DFM projects as per the program timelines.
· Will possess a working application/knowledge of medical device regulatory requirements and standards.
· Write phase review updates and reports for design verification/process validation, complete testing, and transfer to manufacturing. Including Manufacturing Process Instruction (MPI), Lot History Record (LHR), Bill of Material (BOM) and other production documentation.
· Lead and directly participate in the design and testing of manufacturing fixtures and equipment.
· Directs DFM activities within the R&D program team.
· Lead and be responsible for the design transfer into operations


Desired Skills and Experience

  • ·         The ability to manage resource, time, budget, and people are required. This person must have the ability to work cross-functionally with teams.
  • ·         Proven application of statistical techniques, Design of Experiment (DOE), and Design for Manufacturing (DFM) experience is preferred.
  • ·         Knowledge of and compliance with applicable Quality System requirements (e.g., FDA, ISO & MDD) and experience working in a regulated environment is preferred.
  • ·         Strong written and verbal communication skills to communicate effectively at all levels are required.
  • ·         Good presentation skills to deliver updates and/or presentations effectively to a variety of audiences are required.
  • ·         Able to influence and manage at all levels
  • ·         Proficiency with MS Word, Excel and Project is required. Experience with CAD, preferably SolidWorks is preferred.
  • ·         This position is based in Scarborough and may require up to 20% travel Domestic and International.

Minimum Qualifications


Bachelor’s degree in chemistry, manufacturing engineering, mechanical engineering or industrial engineering preferred.


  • Minimum of 8 years’ experience in new product introduction of Medical Device Products.
  • ·         The ideal candidate will have a minimum of 8 years of demonstrated medical device R&D and manufacturing in a directly related field.
  • Excellent conceptual, analytical, and problem-solving ability.
  • Experience with Design for Manufacturability and Assembly (DFMA).
  • Excellent computer skills – Minitab, Jump, CAD, word processing, and spreadsheets.
  • Good communication skills, both verbal and written, and the ability to effectively interface within a cross-functional team environment.
  • Experienced in modern manufacturing principles and techniques.

Preferred Qualifications

  • Knowledge and experience in CGMP requirements and preferably FDA and ISO 9000 requirements.
  • Six Sigma/DFM/Black belt experience