Principal Process Engineer in Bedford

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. Plans and conducts work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments and related fields. Generally, uses advanced techniques and the modification or extension of theories, concepts and practices in the specialty and/or related disciplines. Maintains a clear overview of a major product development. Makes sound judgments when compromises, necessitated by available time and technical capacity, must be made to meet set objectives. Mentors junior staff.

Responsibilities Key Accountabilities: Essential Functions:

• Acts as an Individual contributor, core team or technical lead for a specific project or product line.
• 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 complex in nature, in alignment with corporate goals.
• Analyzes and interprets data, identifying trends and formulating the next steps, while effectively performing trade off analysis, 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 complex components and functions.
• Experience leading the development of test strategies, execution process validation, including but not limited to: IQ, OQ, PQ, Guage R&R, DoE, process capability.
• Must have experience in design requirements and risk management (pFMEA), driving risk mitigation to closure in collaboration with cross-functional teams.
• Experience working with electromechanical assemblies and instrumentation and test fixtures.
• Evaluates complex designs or processes, with respect to acceptability, suitability and cost.
• Recommends preferred design options.
• Presents trade-off, if required by the function.
• Identifies product defects and able to recognize outliers in results.
• Able to explain and document product defects and their impact.
• Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.
• Leads without authority & provides technical guidance to engineers and technicians assigned to him/her on a given project.
• Provides mentoring within or outside of their department.
• Provides technical support for or leads CAPA or complaint investigations.
• Partner with Quality Engineering and Regulatory teams to support phase planning readiness and contribute to the Design History File (DHF).
• Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.
• Responsible for estimating and planning validation activities across the development lifecycle.
• Transition validated process to operations: provide training, procedures, and on-floor support.

Secondary Functions:

• May review and provide input to deliverables from other functions.
• Recommends and drives improvement initiatives and motivates others to implement.
• May be assigned CAPA ownership.

Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities:

• Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking.
• Technically adept and confident Leadership: Accountability, Decision Making, Influence, Communication.
• Mentoring.

Qualifications Minimum Knowledge & Experience Required for the Position:

• Education: Bachelor's degree in Engineering, Science or a related field.
• Experience: Twelve years of product development or relevant experience; Eight to ten 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.
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required.
• International Mobility: Required: No.
• Travel Requirements: Some domestic and international travel may be required.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment, or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law.