Function: Research & Development

Summary

EdgeOne Medical is seeking an Engineering Manager to join our growing organization.

Please send your resume and a cover letter to careers@edgeonemedical.com and includeEngineering Manager in the Title.

Essential Duties and Responsibilities

• Manage and develop a team of EdgeOne Medical technical staff. Create opportunities for professional development through feedback, mentoring and other tools.
• Act as technical reviewer on documentation generated by engineering team, including protocols, reports, investigations plans, deviations, etc.
• Continuously improve the engineering laboratory: technical capabilities, equipment, best practices, documentation, and throughput.
• Engineering department accountability for qualification, calibration, and maintenance of equipment. (Coordinate resources supporting these tasks. Partner with quality department.)
• Act as technical lead for select Client medical device/combination product programs which may require test method development and validation, refinement of Design Input Requirements, and planning/execution of Verification and Validation activities and more.
• Analyze data, deduce logical next steps, and present to clients (Statistical calculations may include upper/lower tolerance limits, sample size determination, normality checks/transformations, etc.)
• Resolve issues and troubleshoot devices/equipment through data-driven and experiential approaches.
• Participate in strategic objectives relating to development and expansion of laboratory and testing service offerings. Help build and establish relationships with new clients, assess/recommend development strategies to clients, and prepare proposals.
• Manage laboratory activities performed by internal resources and coordinate work that is subcontracted to external parties (CMO, CDO, Contract Laboratory, etc).
• Apply critical thinking and risk-based considerations to technical decisions and E1M policies. Support EdgeOne organization in optimizing internal operating processes relating to laboratory operations and/or technical documentation.
• Contribute to development of thought leadership and/or technical papers and presentations.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Degree in Engineering or equivalent employment experience/certification. Minimum of 15-20 years collective experience as medical device engineer or project lead supporting development of range of medical devices from single-use disposable to complex, integrated systems.
• Strong leadership, management, facilitation, mentoring, and communication skills.
• Demonstrated track record of achieving project timelines and project objectives.
• Strong multi-tasking and project management skills. (Flex to meet urgent and changing needs.)
• Must be able to interact and communicate with all levels of the organization.
• Motivation and desire to share your knowledge with the broader industry community.
• Knowledge of device manufacturing, materials and key industry standards (ISO 20072, ISO 11040, ISO 11608, etc.) is preferred.
• Ability to problem solve, identify root causes, and implement corrections as part of investigations.
• Recognized as Subject Matter Expert in one or more technical areas.
• Wide technical expertise in areas of design (CAD experience), manufacturing (molding, machining, assembly), Test Method Development and Validation, Design Verification, Root Cause Failure Analysis, Statistics, Laboratory Equipment troubleshooting, and Design History File documentation
• Preference for prior experience growing a service-based organization.

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.