Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA.
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.
- Demonstrated cross-functional leadership delivering electro-mechanical medical devices or systems through the product development lifecycle.
- Ability to think at a system level and work collaboratively across functions to identify and mitigate risk and execute technically complex problems.
- 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.
- 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.
- Technical expertise in more than one or a subject matter expert in at least 1 area.
- 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.
- Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.
- 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)
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:
- Electro-Mechanical Design experience (concept through production, across multiple fabrication methods)
- Experience with robotics electro-mechanical integration
- Experience with a programming language prefered, but not required
- 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, Systems Thinker, Team Player
- Mentoring and Technical Coaching
Minimum Knowledge & Experience Required for the Position:
- Bachelor's degree in Engineering, Science or a related field
- 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
- Some domestic and international travel may be required.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V