R&D Manager, Systems Engineer

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 adequatelyand 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…