R&D Manager, Systems Engineer

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.

Position Summary

Functional management position responsible for engineering activities an entire Functional Group The position involves management and development of a staff of technical professionals, ensuring projects are staffed adequately and in alignment with corporate objectives. Additional requirements include the ability to drive business results and capability to act as an ambassador of the Werfen culture and values. Will interface and coordinate work activities with Project Management, and other departments such as Software, Analytical, Quality, Service and Marketing.

Skill Level and Background:

System Experience (Platform Integration/Architecture):

• Must have a bachelor's degree in Electrical Engineering, Systems Engineering, Software Engineering or closely related field. Advanced degree is preferred
• Must have a proven track record in a management or leadership role with a demonstrated record managing and/or developing systems engineering team capability. (10-15 years experience) (team of 10+ ppl strongly desired)
• Must have strong project-engineering or project-management acumen with deep understanding of traditional waterfall and Agile methodologies. PMP/PMI certifications are a plus. (e.g. resource allocation and workload balancing, work-breakdown structure (WBS), PI planning)
• Strong Project Management skills & Cross-Functional Leadership Must be a dynamic people leader focused on engagement, empowerment, and results. Player-coach profile desired.
• Must have experience leading hardware, software, and systems engineering functions as an architect is a must. Instrumentation and measurement equipment background is preferred.
• Should have experience working alongside reagent development teams.
• Should act as a functional champion of system engineering discipline across HWE. INCOSE membership a plus.
• A demonstrated ability in the application of system-level approach to trouble-shooting and root-cause determination. Experience utilizing root-case determination methods (e.g. Ishikawa, 5-Why, Fishbone, etc.) desired.
• Experience developing and executing comprehensive system strategies for system integration, verification, and validation according to standard operating procedures and design controls.
• Proven track record in prototyping, rapid iteration, and early-stage product development
• Understands compliance concepts and testing requirements (IEC 60601) for Noise/EMI/EMC mitigation.
• Familiarity with Design Control & Risk Management according to international standards (ISO-13485, ISO-14971) desired.
• Familiarity with Human Factors & Usability Engineering

Leadership:

• Technical authority that helps guide the decision-making process for Coagulation programs
• Credible leader who can influence with strong organizational and prioritization skills with a results-oriented mindset
• Leads the definition of the instrument integration strategy driving alignment across cross-functional teams in R&D
• Leads the development of System Level Architecture
• Manages a team responsible for planning and execution of the integration strategy together with Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering, Coag Analytical, and Reagent Development
• Partner with the Project Manager to define the Integration Schedule and resources (FTE, Instruments, Tools)
• Drives diverse technical team to find alternative solutions to manage through development and integration roadblocks
• Supports subsystem teams in managing complexity, interdependencies, modularity
• Leads the technical decision-making process to drive consensus amongst the core team for go, no-go, or redirect decisions in all phases of the project (concept, feasibility, development)
• Mentors junior engineers, and are available and engaged with the entire program team

Must Have:

• People Management (team greater than 10 people)
• Class II or III Medical device experience under IEC 60601, FDA
• Proven ability to effectively manage a team (Internal and External)
• Ability to communicate ideas and information clearly, effectively and frequently
• Direct knowledge of regulatory requirements and industry standards in medical device industry
• Strong project and people management skills

Minimum Knowledge & Experience Required

• Education: Bachelors Degree in Engineering, Science, or related Field.
• Experience
  • Eight to ten years of product development experience, depending on degree
  • Six years of experience in Functional Management
  • 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 experience highly desirable
• Additional skills/ Knowledge
  • Language" Proficiency in English language required

Skills & Capabilities

The ideal candidates for this position will exhibit the following skills and capabilities:

• Root Cause Analysis, Creative Problem Solving, Critical Thinking
• Technical capability and confidence
• Accountability, Decision Making, Influence, Communication
• Coaching & Mentoring

Travel Requirements

Up to 10% of time

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