Werfen North America · 2 days ago
R&D Manager, Systems Engineer
Bedford, MA
Full-time
Onsite
Director/Executive
$180K/yr - $210K/yr
6+ years expWerfen North America is a company focused on advancing medical technology, and they are seeking an R&D Manager, Systems Engineer to lead engineering activities within a functional group. The role involves managing a team of technical professionals, driving business results, and ensuring project alignment with corporate objectives while interfacing with various departments.
Health CareManufacturing
Responsibilities
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
Must have strong project-engineering or project-management acumen with deep understanding of traditional waterfall and Agile methodologies
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
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
A demonstrated ability in the application of system-level approach to troubleshooting 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
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
Qualification
Required
Must have a bachelor's degree in Electrical Engineering, Systems Engineering, Software Engineering or closely related field
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
Strong Project Management skills & Cross-Functional Leadership Must be a dynamic people leader focused on engagement, empowerment, and results
Must have experience leading hardware, software, and systems engineering functions as an architect
A demonstrated ability in the application of system-level approach to trouble-shooting and root-cause determination
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)
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
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
Language: Proficiency in English language required
Preferred
Advanced degree is preferred
Instrumentation and measurement equipment background is preferred
Should have experience working alongside reagent development teams
INCOSE membership a plus
Experience utilizing root-case determination methods (e.g. Ishikawa, 5-Why, Fishbone, etc.) desired
Familiarity with Human Factors & Usability Engineering
in vitro medical experience highly desirable
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation and sick leave
Participation in a commission plan
Performance-based bonus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase