Open Position: Project Manager II

Function:  Project Management

Summary

EdgeOne Medical (E1M) is seeking an experienced and highly motivated Project Manager to join our growing team. This role leads cross-functional combination product and medical device testing programs to achieve on-time, on-budget delivery for multiple clients simultaneously. Serves as the primary client-facing project leader responsible for coordinating laboratory testing activities, driving execution across engineering and quality teams and ensuring alignment between client expectations and internal deliverables. Experience with combination products is essential. The individual must be capable of effectively engaging with clients on technical topics related to device testing, troubleshooting, investigations, and verification activities and may serve as the technical lead for select programs depending on experience and project complexity.

Programs may include, but are not limited to, design verification, characterization testing, method validation, complaints testing, engineering investigations and container closure integrity testing (CCIT) for devices such as autoinjectors, syringes, inhalers, pumps, wearable injectors and vial access systems. Experience supporting Design History File (DHF) activities and broader medical device development processes is preferred.

This role requires a strong on-site presence to facilitate rapid communication, testing prioritization, issue resolution, and day-to-day coordination of laboratory-based projects.  

Please note that this is an on-site position based in Wheeling, IL. We are currently considering local candidates only, and relocation assistance is not available.

Please send your resume and a cover letter to career@edgeonemedical.com and include Project Manager II in the Title.

Essential Duties and Responsibilities

  • Leads multiple combination product and medical device testing programs simultaneously to ensure testing activities and deliverables are executed on time, on budget and aligned with client expectations.
  • Drives execution and coordination across engineering, laboratory testing, quality, and project management functions to maintain schedule adherence and laboratory throughput.
  • Leads daily coordination activities, project team meetings, and escalation discussions to rapidly resolve technical, operational and scheduling issues impacting testing execution.
  • Works closely with laboratory, engineering and quality teams on-site to coordinate testing priorities, equipment availability, staffing alignment and execution of client deliverables across multiple concurrent programs.
  • Effectively engages with clients and internal technical teams regarding medical device and combination product testing methodologies, investigations, troubleshooting activities and verification strategies.
  • May serve as the technical lead for select projects involving device testing, protocol development, data interpretation, engineering investigations and related technical documentation activities.
  • Supports prioritization and execution of laboratory-based testing activities to optimize resource utilization, maintain client responsiveness and accelerate delivery commitments.
  • Maintains strong situational awareness of testing progress, schedule risks, resource constraints, and client priorities across assigned programs.
  • Promotes a culture of accountability, urgency, technical excellence, collaboration and right-first-time execution.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Bachelor’s Degree in Engineering, Biomedical Engineering, Mechanical Engineering, Life Sciences, or related technical field required.
  • 5–10 years of experience in combination product and/or medical device development, testing, engineering, or technical project management environment.
  • Prior experience leading cross-functional testing or technical programs with responsibility for schedule execution, budget management, client communication and delivery of technical deliverables.
  • Experience supporting or leading combination product and medical device testing activities including design verification, characterization testing, method validation, engineering investigations, complaints testing or related laboratory activities.
  • Strong ability to effectively communicate technical information to clients, engineers, laboratory personnel, and quality teams.
  • Demonstrated ability to lead cross-functional technical teams and drive accountability, urgency and execution across multiple concurrent projects.
  • Strong understanding of laboratory operations, testing coordination and management of priorities across multiple active testing programs.
  • Experience working with combination product devices such as autoinjectors, syringes, inhalers, wearable injectors, pumps or vial access systems preferred.
  • Experience supporting Design History File (DHF) activities, technical documentation, and broader medical device development processes is preferred.
  • Working knowledge of applicable regulatory and quality system requirements including cGMP, cGLP, cGDP, ISO standards, and medical device development practices preferred.
  • Demonstrated ability to identify schedule risks, coordinate resolution activities, and maintain client responsiveness in a fast-paced testing environment.
  • Highly organized self-starter with strong leadership presence, technical credibility and ability to operate effectively within an on-site laboratory environment.
  • Strong problem-solving, facilitation, communication and decision-making skills.
  • Proficiency with Microsoft Office tools including Excel, Word, PowerPoint, Teams and project tracking tools.
  • PMP certification or equivalent project management training is beneficial but not required.

Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.