Senior Engineering Group Leader System Engineering

Werfen

Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM) business line we research develop and manufacture customized assays and biomaterials. We operate directly in 30 countries and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe and our workforce is more than 7000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas our commitment to customers and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

Reporting to the Functional Manager responsible for assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture. Receives requirements specifications from the ProjecUProgram Managers and prepares specifications to design develop or integrate technologies required to make a product and its specific derivatives. Responsible for all Functional Specifications and Theory of Operation documents including schematics design layouts detail and assembly drawings bill of materials associated analytical data and any implementation documents. May act as group leader or lead engineer on a major program perform independent development and be responsible for a number of smaller projects.

SkillLeveland Background:

1. SystemExperience(Platform Integration/Risk Management/V&V)

1. Musthave abachelors degree inElectrical Engineering Systems EngineeringBiomedicalEngineeringor closely related field.Advanceddegree is preferred

1. Must have a proventrack recordinamanagementor leadership rolewith ademonstratedrecordmanagingand/or developing systems engineeringteamcapability.(7-10yearsexperience)(team of5 pplstrongly desired)

1. Strong project engineering/managementcapability withexpertisein Waterfall and Agile methodologies. Proven ability to plan and deliver complex programs (resource allocations workload balancing WBS PI planning) while leading and developing high performingteam.

1. Experience leading the development of test strategies exploratory evaluations and formal design verification from early concept through submission readiness.

1. Must haveexperience in designrequirements andrisk management with the ability to translate identified and emerging risks into actionable verification strategies and detailed test plans driving risk mitigation to closure in collaboration with cross-functional teams.

1. Partner withQuality Engineering and Regulatoryteamsto support audit readiness and contribute to the Design History File (DHF)

1. Shouldhave experience in estimating andplanverification and validation activities across the development lifecycle

1. Specify detailed and traceable test cases based on system requirements and risk analysis

1. Organize and lead defect review meetings with relevant team members. Providetimelyupdates on test progress defect status and overall V&V activities.

1. Experience developingand executingcomprehensive system strategiesfor system integration verification and validation according to standard operating procedures and design controls.

1. Understandscompliance concepts and testingrequirements(IEC 60601)forNoise/EMI/EMCmitigation.

1. Experience with risk management tools (e.g. JAMA DOORS Cockpit) with JAMA preferred.

1. Musthave experiencewithDesign Control & Risk Managementaccording to international standards (ISO-13485 ISO-14971) desired.

1. Must befamiliarwithHuman Factors & Usability Engineering

About yourLeadership:

1. Technical authority that helps guide the decision-making process for Coagulation programs

1. Credible leaderwho can influence with strong organizational and prioritization skills with a results-oriented mindset

1. Leads the definition of the instrumentrisk and V&Vstrategy driving alignment across cross-functional teams in R&D

1. Leadswith hands-onapproachin the development of design verification plans andauthoringprotocols that map requirements to objective test methods with defined acceptance criteria.

1. Manages a team responsible for planning and execution of the integration strategy together with Mechanical Engineering Electrical Engineering Software Engineering Systems EngineeringCoagAnalytical and Reagent Development

1. Partnerwith the Project Manager to define theDesign ControlScheduleand resources (FTE Instruments Tools)

1. Drives diverse technical team to find alternative solutions to manage through development and integration roadblocks

1. Supports subsystem teams in managing complexity interdependencies modularity

1. 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)

1. Mentorsjunior engineers andareavailable and engaged with the entire program team

MustHave:

1. People Management (team greater than5people)

1. Class II or III Medical device experience under IEC 60601 FDA

1. Proven ability to effectively manage a team (Internal and External)

1. Ability to communicate ideas and information clearlyeffectivelyandfrequently

1. Direct knowledge of regulatory requirements and industry standards in medical device industry

1. Strong project and people management skills

Minimum Knowledge & Experience Required for the Position:

• Requires a B.S. in Engineering and at least 15 years of experience or an M.S. Degree and at least 10 years of experience in degreed field.
• Must have a demonstrated interest in managing a product development effort.

International Mobility: Required:

• No

Travel requirements:

• <5% of time

The annual base salary range for this role is currently $160000 to $190000. 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.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.