R&D Manager, Systems Engineer

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 bachelors 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 experiencehighly desirable
• Additional skills/ Knowledge
  • Language Proficiencyin 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 $180000 to $210000. 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 sales roles are eligible for participation in a commission plan and our managementand select professional rolesare eligible for a performance-based bonus.