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Base pay range
$175,000.00/yr - $250,000.00/yr Talent Partner | Fuelling growth for CDMOs, CROs, and Pharma Services
| Pragmatic Solution Finder | MSc Psychology
Reporting to the CEO, the Vice President of Engineering will lead product development, technical operations, vendor management, and customer technical services. This includes translating customer requirements into design specifications, coordinating with contract manufacturing, supporting factoring and site acceptance testing (FAT/SAT), as well as validation services (IQ/OQ). The Vice President will lead a team across software, hardware, and systems disciplines, and will play a critical role in cross-functional product planning, execution, and be a member of the Executive Leadership Team. Key Responsibilities Product Development & Lifecycle Ownership Own the end-to-end product development lifecycle - from concept through commercialization - for software, hardware, and integrated systems. Lead development of the engineering roadmap aligned with strategic business goals and market needs. Oversee systems architecture and integration. Define and manage system-level design decisions, interface standards, and testing protocols. Ensure interoperability with customer infrastructure and real-world conditions. Incorporate site requirements and regulatory inputs into design to support successful installations and qualifications. Act as the technical lead and primary liaison to contract manufacturing partner(s). Define and manage detailed specifications, documentation, and performance expectations for vendor-delivered systems. Support customer onboarding and ongoing product performance through structured technical assistance and issue resolution processes. Maintain strong change control, traceability, and documentation for vendor-managed components. Regulatory & Quality Alignment Partner with Quality and Regulatory teams to ensure all engineering activities meet ISO 13485, 21 CFR Part 820, and related compliance standards. Oversee software development lifecycle (SDLC) and ensure proper validation aligned with IEC 62304 and 21 CFR Part 11. Support generation of required DHF documentation, risk files, and design control evidence. Engineering Operations & Team Leadership Build and lead a multidisciplinary engineering team across mechanical, electrical, firmware, software, and systems domains. Implement appropriate lean, agile, or hybrid methodologies to drive efficiency and compliance in hardware-software development. Establish a culture of technical excellence, documentation rigor, and cross-functional collaboration. Field Service Enablement & Global Engineering Strategy Develop the global support framework in coordination with Field Service and Commercial teams, including diagnostic tools, training, and third-party partnerships. Ensure serviceability, remote monitoring capabilities, and escalation support are designed into the product. Build and lead a Customer Technical Service group to support the continuous operation of sterilizers installed at customer sites with service plans, procedures, and training. Outside the US, this could include the management of third-party service providers. Executive Partnership & Strategic Contribution Serve as a member of the Senior Leadership Team, actively contributing to company strategy, budgeting, and growth planning. Present technical risk, opportunity, and roadmap trade-offs to internal stakeholders, board members, and investors. Contribute to IP strategy, platform scalability, and competitive technical differentiation. Support diligence and commercial efforts through technical validation, customer meetings, and investor interactions. Qualifications 10+ years of engineering leadership in regulated hardware/software products, preferably for large platform equipment used in the lab or manufacturing space for the Pharma or Medical device industry. Proven experience managing third-party manufacturing relationships, including FAT/SAT coordination and spec management. Strong understanding of product development process and improving product reliability methodologies. Familiarity with ISO 13485, 21 CFR Part 820, IEC 62304, and related standards. Track record of building and scaling high-performance engineering teams and processes. Strong executive communication, cross-functional alignment, and problem-solving skills. Personal Attributes Visionary leader with a passion for driving and achieving results. Strategic thinker with the ability to translate insights into actionable plans, executing to an incredibly high standard. Collaborative team player with a commitment to fostering a positive and inclusive work environment. Resilient and adaptable to changing business dynamics and market conditions. An agent of change, able to constructively challenge the status quo in pursuit of collective success, utilizing data-driven metrics to support recommendations or decisions. Solutions-oriented, takes ownership of critical issues and challenges with rigor and drive. This is an incredibly exciting opportunity to lead the engineering group of a high growth business, at a critical point in their evolution. If you think you have the skills and energy to help lead this organization on it's future strategy then we want to hear from you! Seniority level
Executive Employment type
Full-time Job function
Engineering, Product Management, and Customer Service
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$175,000.00/yr - $250,000.00/yr Talent Partner | Fuelling growth for CDMOs, CROs, and Pharma Services
| Pragmatic Solution Finder | MSc Psychology
Reporting to the CEO, the Vice President of Engineering will lead product development, technical operations, vendor management, and customer technical services. This includes translating customer requirements into design specifications, coordinating with contract manufacturing, supporting factoring and site acceptance testing (FAT/SAT), as well as validation services (IQ/OQ). The Vice President will lead a team across software, hardware, and systems disciplines, and will play a critical role in cross-functional product planning, execution, and be a member of the Executive Leadership Team. Key Responsibilities Product Development & Lifecycle Ownership Own the end-to-end product development lifecycle - from concept through commercialization - for software, hardware, and integrated systems. Lead development of the engineering roadmap aligned with strategic business goals and market needs. Oversee systems architecture and integration. Define and manage system-level design decisions, interface standards, and testing protocols. Ensure interoperability with customer infrastructure and real-world conditions. Incorporate site requirements and regulatory inputs into design to support successful installations and qualifications. Act as the technical lead and primary liaison to contract manufacturing partner(s). Define and manage detailed specifications, documentation, and performance expectations for vendor-delivered systems. Support customer onboarding and ongoing product performance through structured technical assistance and issue resolution processes. Maintain strong change control, traceability, and documentation for vendor-managed components. Regulatory & Quality Alignment Partner with Quality and Regulatory teams to ensure all engineering activities meet ISO 13485, 21 CFR Part 820, and related compliance standards. Oversee software development lifecycle (SDLC) and ensure proper validation aligned with IEC 62304 and 21 CFR Part 11. Support generation of required DHF documentation, risk files, and design control evidence. Engineering Operations & Team Leadership Build and lead a multidisciplinary engineering team across mechanical, electrical, firmware, software, and systems domains. Implement appropriate lean, agile, or hybrid methodologies to drive efficiency and compliance in hardware-software development. Establish a culture of technical excellence, documentation rigor, and cross-functional collaboration. Field Service Enablement & Global Engineering Strategy Develop the global support framework in coordination with Field Service and Commercial teams, including diagnostic tools, training, and third-party partnerships. Ensure serviceability, remote monitoring capabilities, and escalation support are designed into the product. Build and lead a Customer Technical Service group to support the continuous operation of sterilizers installed at customer sites with service plans, procedures, and training. Outside the US, this could include the management of third-party service providers. Executive Partnership & Strategic Contribution Serve as a member of the Senior Leadership Team, actively contributing to company strategy, budgeting, and growth planning. Present technical risk, opportunity, and roadmap trade-offs to internal stakeholders, board members, and investors. Contribute to IP strategy, platform scalability, and competitive technical differentiation. Support diligence and commercial efforts through technical validation, customer meetings, and investor interactions. Qualifications 10+ years of engineering leadership in regulated hardware/software products, preferably for large platform equipment used in the lab or manufacturing space for the Pharma or Medical device industry. Proven experience managing third-party manufacturing relationships, including FAT/SAT coordination and spec management. Strong understanding of product development process and improving product reliability methodologies. Familiarity with ISO 13485, 21 CFR Part 820, IEC 62304, and related standards. Track record of building and scaling high-performance engineering teams and processes. Strong executive communication, cross-functional alignment, and problem-solving skills. Personal Attributes Visionary leader with a passion for driving and achieving results. Strategic thinker with the ability to translate insights into actionable plans, executing to an incredibly high standard. Collaborative team player with a commitment to fostering a positive and inclusive work environment. Resilient and adaptable to changing business dynamics and market conditions. An agent of change, able to constructively challenge the status quo in pursuit of collective success, utilizing data-driven metrics to support recommendations or decisions. Solutions-oriented, takes ownership of critical issues and challenges with rigor and drive. This is an incredibly exciting opportunity to lead the engineering group of a high growth business, at a critical point in their evolution. If you think you have the skills and energy to help lead this organization on it's future strategy then we want to hear from you! Seniority level
Executive Employment type
Full-time Job function
Engineering, Product Management, and Customer Service
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