Senior Process Engineer

Werfen•Bedford, MA

25d

About The Position

Position Summary: Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function. This Senior Engineer in the Process Development Engineering group is responsible for developing and implementing test processes for the manufacture of critical assemblies in medical diagnostic systems that are electro-mechanical in nature. Create complex automated test fixtures, from conceptual design to hardware selection & integration as well as software control systems, documentation, and validation with heavy focus on LabVIEW and TestStand development. Collaborate closely with both R&D and manufacturing across all phases of development. Independently evaluate, select, and apply standard engineering techniques, procedures, and criteria.

Requirements

Statistical Analysis, Root Cause Analysis, Creative Problem Solving, Critical Thinking
Technically adept and confident
Leadership: Accountability, Decision Making, Influence, Communication
Mentoring
Expertise in test fixture development
Strong foundation in electrical engineering concepts
Strong understanding of electro-mechanical systems.
General knowledge of statistics, working knowledge of Minitab
Strong teamwork, organization, and communication skills
Experience in robotic or automated systems.
Required: strong in LabVIEW and TestStand
Bachelor's degree in Engineering, Science or a related field
Eight years of product development or relevant experience
Four to six years of product development or relevant experience for advanced degrees
For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
Proficiency in English language required
No

Nice To Haves

Desired: process validation, CAD design (Creo preferred), familiarity with Python
In vitro medical device experience highly desired.

Responsibilities

Leads and develops new test methods for manufacturing, including but not limited to:
Defining specifications
Designing & procuring fixtures
Outsourcing fixtures and management of supplier deliverables
Controlling hardware with LabVIEW and/or TestStand
Automation and motion control
Communicating with databases
Optimizing processes conditions
Fixture design
Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability
Accountable for the completion of assigned deliverables in accordance with approved schedules.
Authors documentation and participates in activities in support of design control
Independently plans, performs & prioritizes tasks that are moderately complex in nature, in alignment with corporate goals.
Analyzes and interprets data, identifying trends and formulating the next steps, if required by the function.
Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for moderately complex components and functions.
Identifies product defects and recognizes outliers in results. Can explain and document product defects and their impact.
Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations or technical summaries.
Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others.
Provides technical support for or leads investigations in support of development and/or on-market activities.
Independently generates predictable schedules for activities related to assigned projects
May review and provide input to deliverables from other functions.
Independently generates predictable schedules for activities related to assigned projects.
Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others.
Recommends and implements improvement initiatives to aid department practices.