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Werfen · 2 months ago

R&D Manager, Systems Engineer

US-MA-Bedford

Full-time

Onsite

Director/Executive

8+ years exp

Werfen is a company focused on engineering activities within a functional group. The R&D Manager, Systems Engineer will manage and develop a team of technical professionals, drive business results, and coordinate work activities across various departments.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Functional management position responsible for engineering activities an entire Functional Group

Management and development of a staff of technical professionals, ensuring projects are staffed adequately and in alignment with corporate objectives

Drive business results and act as an ambassador of the Werfen culture and values

Interface and coordinate work activities with Project Management, and other departments such as Software, Analytical, Quality, Service and Marketing

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

Systems EngineeringMedical Device ExperienceProject ManagementAgile MethodologiesRoot Cause AnalysisCross-Functional LeadershipCoaching & MentoringCreative Problem SolvingCritical ThinkingCommunication

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 is a must

Should have experience working alongside reagent development teams

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) desired

Familiarity with Human Factors & Usability Engineering

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

PMP/PMI certifications are a plus

Instrumentation and measurement equipment background is preferred

INCOSE membership a plus

Experience utilizing root-case determination methods (e.g. Ishikawa, 5-Why, Fishbone, etc.) desired

in vitro medical experience highly desirable

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen 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)