Project Manager

Project Manager

The R&D Project Manager is responsible for owning and driving the successful execution of customer programs within Aptyx's Life Sciences business, supporting the development and commercialization of Class II and Class III medical devices in a regulated CDMO environment. This role leads cross-functional teams across the full product lifecycle from concept and feasibility through design transfer and manufacturing launch ensuring delivery against scope, schedule, budget, quality, and customer expectations.

This position serves as the primary customer liaison and internal project leader, combining strong technical acumen with exceptional communication and customer service skills. The Project Manager is accountable for building trusted customer relationships, translating complex technical requirements into actionable plans, and driving projects with urgency, discipline, and results-oriented execution. Success in this role directly impacts customer satisfaction, long-term partnerships, and business growth.

Core Competencies & Responsibilities

1. Project Ownership & Results-Driven Execution

• Own full lifecycle delivery of multiple concurrent life sciences / medical device programs.
• Develop and actively manage detailed project plans including scope, timelines, milestones, deliverables, and budgets.
• Establish clear objectives, success criteria, and critical path and drive execution with urgency and accountability.
• Proactively remove barriers, maintain momentum, and ensure teams are aligned to deliver results.
• Lead stage-gate reviews and ensure milestone readiness and on-time delivery.
• Escalate risks and issues early and drive timely resolution.

• Customer Partnership & Relationship Leadership

• Act as the primary point of contact and trusted partner for customers throughout the project lifecycle.
• Build strong, collaborative relationships through responsiveness, transparency, and technical credibility.
• Lead all customer communications including status updates, technical discussions, and issue resolution.
• Translate customer needs into clear internal requirements and ensure alignment across all functions.
• Manage expectations related to scope, schedule, cost, and technical feasibility while maintaining a high level of customer satisfaction.
• Partner with Business Development to support proposals, quoting, and scope definition.
• Ensure a seamless transition from commercial agreements to execution, maintaining alignment with customer commitments.

• Technical Leadership & Cross-Functional Collaboration

• Leverage engineering background to effectively engage in technical discussions with customers and internal teams.
• Lead and coordinate cross-functional teams including R&D, Quality, Manufacturing, Supply Chain, Regulatory, and Customer Service.
• Drive alignment across technical, operational, and commercial stakeholders.
• Influence without authority in a matrixed environment to ensure accountability and results.
• Foster strong internal and external partnerships to enable efficient and effective project execution.

• Risk Management & Problem Solving

• Identify and proactively manage risks related to scope, schedule, technical challenges, and resources.
• Develop mitigation strategies and contingency plans with clear ownership.
• Lead structured problem-solving efforts with a focus on speed, quality, and customer impact.
• Anticipate challenges and act before they impact project success or customer satisfaction.
• Capture lessons learned and drive continuous improvement.

• Regulatory, Quality & Design Transfer Execution

• Ensure compliance with FDA regulations, ISO 13485, and design control requirements.
• Drive completion of all design control deliverables, documentation, and reviews.
• Lead projects through design transfer with a strong focus on manufacturability and readiness.
• Partner with Manufacturing and Quality teams to ensure successful product launch and scale-up.
• Coordinate with external partners and suppliers for tooling, materials, and specialized services.
• Ensure all outputs support verification, validation, and commercialization requirements.

• Operational & Financial Performance

• Own project financials including budget tracking, forecasting, and cost control.
• Monitor KPIs such as schedule adherence, milestone completion, and margin performance.
• Manage scope changes and protect project profitability.
• Contribute to revenue growth through strong execution and customer satisfaction.
• Support broader site and business performance objectives.

Education

• Bachelor's or Master's degree in Engineering required
• PMP or equivalent certification preferred

Experience, Skills, and Abilities

• 5+ years of engineering experience required
• 5+ years of project management or project engineering experience preferred
• Experience in Class II and/or Class III medical device development strongly preferred
• Strong knowledge of design controls and regulated product development
• Demonstrated ability to build strong customer relationships and lead customer-facing programs
• Excellent communication, presentation, and customer service skills
• Proven ability to drive results in a fast-paced, matrixed environment
• Strong analytical, problem-solving, and decision-making capability
• Proficiency with Microsoft Project or equivalent PM tools

Performance Measures

• On-time, on-budget delivery of project scope and milestones
• Customer satisfaction, retention, and partnership growth
• Project profitability and revenue performance
• Regulatory and SOP compliance
• Successful design transfer and commercialization outcomes
• Effectiveness in driving cross-functional execution