Principal Process Engineer at Werfen GmbH

Bedford, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Oct, 26

Salary

165000.0

Posted On

17 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Analysis, Root Cause Analysis, Creative Problem Solving, Critical Thinking, Leadership, Decision Making, Influence, Communication, Mentoring, Process Validation, Risk Management, Design Control, pFMEA, DoE, Gauge R&R, CAPA

Industry

Medical Equipment Manufacturing

Description

Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview 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. 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. The annual base salary range for this role is currently $150,000 to $165,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. 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. Budget Managed: (if applicable) N/A Internal Networking/Key Relationships: To be determined based on department needs, to include interactions such as: Will interface on a regular basis with groups across the organization as needed 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. Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 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. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

Lead the research, design, and development of medical diagnostic system processes and components while mentoring junior staff. Accountable for executing complex deliverables, managing risk mitigation, and transitioning validated processes to operations.