R&D Manager, Systems Engineer at Werfen GmbH

Bedford, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

08 May, 26

Salary

210000.0

Posted On

07 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Systems Engineering, Project Management, Leadership, Root Cause Analysis, Problem Solving, Critical Thinking, Compliance, Risk Management, Human Factors, Usability Engineering, Instrumentation, Measurement Equipment, Agile Methodologies, Waterfall Methodologies, Prototyping, Verification, Validation

Industry

Medical Equipment Manufacturing

Description

Introduction 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 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. Responsibilities 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 Qualifications 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 The annual base salary range for this role is currently $180,000 to $210,000. 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. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus. 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

The R&D Manager will be responsible for managing engineering activities within a functional group, ensuring projects align with corporate objectives. This includes leading a team, driving integration strategies, and collaborating with various departments.