Senior Manager, R&D – Cold Storage OEM

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AI Summary

Lead a multidisciplinary team in developing OEM cold storage solutions for laboratory, clinical, and medical device markets. Ensure product quality, compliance, and speed to market through disciplined New Product Development execution. Requires 10+ years of product development experience, 3+ years of leadership, and familiarity with regulated environments.

Key Highlights
Lead OEM Product Development team for cold storage products.
Ensure adherence to ISO 13485 design control processes.
Collaborate with cross-functional teams and global OEM partners.
Key Responsibilities
Lead and manage the OEM Product Development team, supporting new and existing lab equipment programs.
Own development, specification, and qualification aligned with customer and product requirements and regulatory expectations.
Provide technical leadership and hands-on problem solving related to system evaluation and requirements compliance.
Ensure adherence to ISO 13485 design control processes, including design planning, risk management, verification, validation, and commercialization activity performed by OEM.
Oversee creation and maintenance of Design History Files (DHF), design specifications, drawings, and technical documentation throughout the product lifecycle.
Lead and facilitate design reviews, risk assessments, and product safety evaluations.
Support product approval strategies, including test methods, acceptance criteria, and compliance to applicable standards (e.g., UL, IEC, FDA, Energy Star).
Partner closely with Product Management, Quality, Regulatory, Supply Chain, and PMO throughout the NPD process.
Support product road-mapping activities by translating customer and market needs into actionable technical strategies.
Collaborate with global OEM partners robust production readiness and scalability.
Establish and sustain standard work, design best practices, and common engineering processes.
Apply Lean, PPI, VAVE, and simulation to accelerate development and improve value.
Foster a strong safety culture and continuous improvement mindset across the team.
Recruit, develop, and mentor engineers, building technical depth and leadership capability within the team.
Set clear performance expectations and support career development through coaching and feedback.
Balance strategic planning with hands-on technical engagement to deliver results.
Technical Skills Required
Refrigeration systems Mechanical design Control systems integration ISO 13485 design controls PLM systems Lean PPI VAVE Simulation
Benefits & Perks
Relocation support may be available
Nice to Have
Master's degree
Experience developing ULT, HVAC/R, or temperature-controlled systems
Hands-on experience with PLM systems and change management

Job Description


Work Schedule

Standard (Mon-Fri)


Environmental Conditions

Office


As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them.


This is an onsite role in Marietta, OH. Relocation support may be available.


DESCRIPTION:

As Sr. Manager, R&D – Cold Storage OEM, you will lead a team to manage OEM solutions for cold storage products used in laboratory, clinical, and medical device markets. You will manage a multidisciplinary design team responsible for original equipment manufacturer product development, guiding products from concept through commercialization.

In this highly visible leadership role, you will ensure products meet customer needs, regulatory requirements, and business objectives, utilizing a disciplined New Product Development (NPD) execution. Your work will directly influence product quality, compliance readiness, speed to market, and long-term platform sustainability.


WHAT YOU WILL DO:

Technical & Program Leadership

  • Lead and manage the OEM Product Development team, supporting new and existing lab equipment programs.
  • Own development, specification, and qualification aligned with customer and product requirements and regulatory expectations.
  • Provide technical leadership and hands-on problem solving related to system evaluation and requirements compliance.

Design Control & Regulatory Compliance

  • Ensure adherence to ISO 13485 design control processes, including design planning, risk management, verification, validation, and commercialization activity performed by OEM.
  • Oversee creation and maintenance of Design History Files (DHF), design specifications, drawings, and technical documentation throughout the product lifecycle.
  • Lead and facilitate design reviews, risk assessments, and product safety evaluations.
  • Support product approval strategies, including test methods, acceptance criteria, and compliance to applicable standards (e.g., UL, IEC, FDA, Energy Star).

Cross-Functional Collaboration

  • Partner closely with Product Management, Quality, Regulatory, Supply Chain, and PMO throughout the NPD process.
  • Support product road-mapping activities by translating customer and market needs into actionable technical strategies.
  • Collaborate with global OEM partners robust production readiness and scalability.

Operational Excellence & Continuous Improvement

  • Establish and sustain standard work, design best practices, and common engineering processes.
  • Apply Lean, PPI, VAVE, and simulation to accelerate development and improve value.
  • Foster a strong safety culture and continuous improvement mindset across the team.

People Leadership

  • Recruit, develop, and mentor engineers, building technical depth and leadership capability within the team.
  • Set clear performance expectations and support career development through coaching and feedback.
  • Balance strategic planning with hands-on technical engagement to deliver results.
  • Travel: Up to 10% domestic with limited international travel.


REQUIREMENTS:

Education

  • Bachelor’s degree in mechanical engineering, electrical engineering, mechatronics, computer engineering, or related technical discipline
  • Master’s degree preferred

Experience

  • 10+ years of product development experience with complex electromechanical systems, preferably refrigeration or thermal systems
  • 3+ years of people management or senior technical leadership experience
  • Experience developing ULT, HVAC/R, or temperature-controlled systems strongly preferred
  • Experience in regulated product development environments (medical device, laboratory equipment, or life sciences)
  • Demonstrated experience applying ISO 13485 design controls
  • Hands-on experience with PLM systems and change management
  • Experience managing project budgets, schedules, and resource planning
  • Familiarity with Lean, PPI, or continuous improvement methodologies

Knowledge, Skills, And Abilities

  • Strong technical foundation in refrigeration systems, mechanical design, and control systems integration
  • Ability to translate complex technical concepts into clear business and customer value
  • Proven leadership, communication, and cross-functional collaboration skills
  • Strong problem-solving mindset with data-driven decision making
  • Ability to manage multiple programs in a fast-paced, matrixed environment
  • Experience facilitating design reviews, risk assessments, and technical trade studies
  • Commitment to safety, quality, and operational excellence

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