Senior Engineering Group Leader - System Engineering

Werfen•Bedford, MA

10h•$160,000 - $190,000

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain, and is a worldwide leader in specialized diagnostics in areas such as Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through its Original Equipment Manufacturing (OEM) business line, Werfen researches, develops, and manufactures customized assays and biomaterials. The company operates directly in 30 countries and in more than 100 territories through distributors, with Headquarters and Technology Centers in the US and Europe, and a workforce of over 7,000 employees. Werfen's success stems from its focus on rapidly evolving diagnostic areas, commitment to customers, and dedication to innovation and quality, aiming to provide healthcare professionals with valuable solutions to improve hospital efficiency and patient care.The Senior Engineering Group Leader reports to the Functional Manager and is responsible for assigning and overseeing the practical use of technology across multiple programs, ensuring the proper use of common architecture. This role involves receiving requirements specifications from Project/Program Managers and preparing specifications to design, develop, or integrate technologies for products and their derivatives. The leader is accountable for all Functional Specifications and Theory of Operation documents, including schematics, design layouts, detail and assembly drawings, bill of materials, associated analytical data, and implementation documents. The individual may also act as a group leader or lead engineer on major programs, perform independent development, and manage several smaller projects.

Requirements

Bachelor’s degree in Electrical Engineering, Systems Engineering, Biomedical Engineering or closely related field.
Proven track record in a management or leadership role with a demonstrated record managing and/or developing systems engineering team capability (7-10 years experience).
Strong project engineering/management capability with expertise in Waterfall and Agile methodologies.
Proven ability to plan and deliver complex programs (resource allocations, workload balancing, WBS, PI planning) while leading and developing high performing team.
Experience leading the development of test strategies, exploratory evaluations, and formal design verification from early concept through submission readiness.
Experience in design requirements and risk 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.
Partner with Quality Engineering and Regulatory teams to support audit readiness and contribute to the Design History File (DHF).
Experience in estimating and plan verification and validation activities across the development lifecycle.
Specify detailed and traceable test cases based on system requirements and risk analysis.
Organize and lead defect review meetings with relevant team members.
Provide timely updates on test progress, defect status, and overall V&V activities.
Experience developing and executing comprehensive system strategies for system integration, verification, and validation according to standard operating procedures and design controls.
Understands compliance concepts and testing requirements (IEC 60601) for Noise/EMI/EMC mitigation.
Experience with risk management tools (e.g., JAMA, DOORS, Cockpit).
Familiar with Human Factors & Usability Engineering.
People Management (team greater than 5 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.
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.
Demonstrated interest in managing a product development effort.

Nice To Haves

Advanced degree is preferred.
Experience managing a team of 5+ people is strongly desired.
Experience with JAMA risk management tool is preferred.
Experience with Design Control & Risk Management according to international standards (ISO-13485, ISO-14971) is desired.

Responsibilities

Assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture.
Receives requirements specifications from the Project/Program 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.
Help guide the decision-making process for Coagulation programs as a technical authority.
Influence with strong organizational and prioritization skills with a results-oriented mindset.
Lead the definition of the instrument risk and V&V strategy driving alignment across cross-functional teams in R&D.
Lead with hands-on approach in the development of design verification plans and authoring protocols that map requirements to objective test methods with defined acceptance criteria.
Manage 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 Design Control Schedule and resources (FTE, Instruments, Tools).
Drive diverse technical team to find alternative solutions to manage through development and integration roadblocks.
Support subsystem teams in managing complexity, interdependencies, modularity.
Lead 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).
Mentor junior engineers, and be available and engaged with the entire program team.