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.
Responsibilities
Skill Level and Background :
System Experience (Platform Integration / Architecture) :
- Must have a b achelor s degree in Electrical Engineering Systems Engineering Software Engineering or closely related field . Advanced degree is preferred
- Must have a p roven track record in a management or leadership role with a demonstrated record managing and / or developing systems engineering team c apability . ( 10-15 years experience ) ( t eam of 10 ppl strongly desired )
- Must have s trong project - engineering or project - management acumen with deep understanding of traditional waterfall and A gile methodologies. PMP / PMI certifications are a plus. ( e.g. resource allocation and workload balancing work-breakdown structure (WBS) PI planning)
- Strong P ro ject M anagement skills & Cross-Functional Leadership Must be a d ynamic people leader focused on engagement empowerment and results. Player-coach profile desired.
- Must have e xperience leading hardware software and systems engineering functions as an architect is a must . Instrumentation and measurement equipment background is preferred.
- Should have e xperience working alongside reagent development team s .
- Should act as a functional champ ion of system engineering discipline across HWE . INCOSE membership a plus.
- A demonstrated a bility in the application of system - level approach to trouble - shooting and root - cause determination . E xperience utilizing root-case determination methods ( e.g. Ishikawa 5-Why Fishbone etc.) desi red .
- Experience developing and execut ing comprehensive system strateg ies 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
- Understand s 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 programsCredible leader who can influence with strong organizational and prioritization skills with a results-oriented mindsetLeads the definition of the instrument integration strategy driving alignment across cross-functional teams in R&DLeads the development of System Level ArchitectureManages 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 DevelopmentPartner 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 roadblocksSupports subsystem teams in managing complexity interdependencies modularityLeads 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 teamMust Have :
People Management ( t eam greater than 10 people)Class II or III Medical device experience under IEC 60601 FDAProven ability to effectively manage a team (Internal and External)Ability to communicate ideas and information clearly effectively and frequentlyDirect knowledge of regulatory requirements and industry standards in medical device industryStrong project and people management skillsQualifications
Minimum Knowledge & Experience Required
Education : Bachelors Degree in Engineering Science or related Field.ExperienceEight to ten years of product development experience depending on degree
Six years of experience in Functional ManagementFor internal candidate promotion : Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experiencein vitro medical experiencehighly desirableAdditional skills / KnowledgeLanguage 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 ThinkingTechnical capability and confidenceAccountability Decision Making Influence CommunicationCoaching & MentoringTravel 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.
Required Experience :
Manager
Key Skills
Laboratory Experience,Vendor Management,Design Controls,C / C++,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development
Employment Type : Full-Time
Experience : years
Vacancy : 1
Monthly Salary Salary : 180000 - 210000