Senior Manager, Hardware Engineering, Biopharma Solutions

Jobtailor; Loveland (CO); On-site; USD 180,000 - 260,000; Full time

Job summary

Jobtailor is seeking a senior hardware engineering leader to guide an instrument platform development group and lifecycle support at Loveland, Colorado. You will define strategy, roadmaps, and priorities while partnering with systems, software, product management, quality, regulatory, and operations to deliver compliant, scalable solutions.

The ideal candidate has extensive experience leading global hardware teams in regulated environments, strong systems thinking, and a track record of

Qualifications

• Bachelor's degree in engineering with 12+ years product development experience, or 10+ years with MS/PhD.
• 5+ years leading hardware engineering teams in a global, matrixed environment.
• Experience developing complex instrumentation in regulated industries (life sciences/diagnostics/medical devices).
• Strong systems architecture, electromechanical design, design controls, risk management, and V&V expertise.

Responsibilities

• Lead and develop a high-performing hardware engineering team for instrument platform development and lifecycle support
• Define engineering strategy, technology roadmaps, resource plans, and functional priorities to support innovation and growth
• Drive hardware development execution with systems, software, product management, quality, regulatory, and operations teams
• Establish and advance engineering best practices including design reviews, risk management, V&V, and design for manufacturability
• Partner with cross-functional leaders to align priorities, manage trade-offs, and deliver business results
• Serve as a technical leader for architecture decisions, technology selection, and complex engineering challenges
• Build organizational capability through continuous improvement, talent development, and DBSystem methods
• Support distributed teams, design reviews, training, and key program activities through periodic travel

Skills

Hardware Engineering Leadership

Systems Architecture Expertise

Risk Management

Design Controls

Product Development in Regulated Envir

Effective Communication

Influencing Across Functions

Team Collaboration

Education

Bachelor's degree in Mechanical, Electrical, Systems, Biomedical Engineering, or related

12+ years of product development experience

MS/PhD considered for 10+ years experience path

Tools

Danaher Business System Tools

Quality Systems

Job description

• Lead and develop a high-performing hardware engineering team responsible for instrument platform development and lifecycle support


• Define engineering strategy, technology roadmaps, resource plans, and functional priorities to support innovation and growth


• Drive hardware development execution in partnership with systems, software, product management, quality, regulatory, and operations teams


• Establish and advance engineering best practices, including design reviews, risk management, reliability, verification and validation, and design for manufacturability


• Partner with cross-functional leaders to align priorities, manage trade-offs, and deliver business results


• Serve as a technical leader for architecture decisions, technology selection, and complex engineering challenges


• Build organizational capability through continuous improvement, talent development, and adoption of Danaher Business System tools and methods


• Support distributed teams, design reviews, training, and key program activities through periodic travel

Requirements

• Bachelor's degree in Mechanical, Electrical, Systems, Biomedical Engineering, or a related discipline with 12+ years of product development experience, or 10+ years with an advanced degree (MS/PhD)


• 5+ years of experience leading hardware engineering teams in a global, matrixed environment


• Proven success developing complex instrumentation products in life sciences, diagnostics, medical devices, biotechnology, or other regulated industries


• Strong expertise in systems architecture, electromechanical design, design controls, risk management, and verification and validation


• Demonstrated ability to influence across functions, drive decisions, and communicate effectively with technical and business stakeholders


• Ability to travel domestically and internationally


• Previous experience building and scaling global hardware engineering organizations, including talent development, organizational design, and process improvement is a plus


• Previous experience leading regulated product development programs involving design controls, quality systems, reliability engineering, and commercialization is a plus


• Advanced expertise or certifications in systems engineering, product development, FMEA, and related disciplines is a plus

Core Competencies

Demonstrates expertise in leading hardware engineering teams and driving product development in regulated industries, with a strong focus on systems architecture, risk management, and design controls. Capable of influencing cross-functional teams and fostering continuous improvement through talent development and best practices.

Highest-signal resume keywords

• Hardware Engineering Leadership


• Systems Architecture Expertise


• Risk Management


• Design Controls


• Product Development in Regulated Industries

ATS Optimization Keywords

Hard Skills

• Electromechanical Design


• Verification and Validation


• Design for Manufacturability


• Product Development


• Complex Instrumentation Development

Soft Skills

• Effective Communication


• Influencing Across Functions


• Team Collaboration

Certifications & Qualifications

• Systems Engineering Certification


• FMEA Certification

Industry Keywords

• Life Sciences


• Diagnostics


• Medical Devices


• Biotechnology


• Regulated Industries

Tools & Technologies

• Danaher Business System Tools


• Quality Systems