As a Project Manager, you will bring strong practical

experience of project management in a rapidly evolving, cross-functional, highly regulated

environment. This role also requires strong cross-functional business acumen, including

technical, manufacturing, finance, quality, clinical, and regulatory-based knowledge.

Responsibilities:

• Overall responsibility of all technical aspects of the device: Design, development, prototype

manufacturing and assembly, test planning and conduction, documentation in DHF

• Developing and managing project plans: Scheduling, risks and mitigation, resourcing, budgeting
• Preparing, presenting and archiving all Design Control reviews and other deliverables to support

project objectives

• Championing continuous improvement: evaluating project for opportunities to improve

performance; continuously monitors risk and mitigates as appropriate

• Project administration – accounting activities associated with projects, including monthly

reporting as required for grants accounting and services billing

• Demonstrating excellent interpersonal and communication skills, in a persuasive and inspirational

style that is timely, proactive, concise, candid, accurate, and clear, with all projects’ members

[including OEMs]

Qualifications and Skills:

• A Bachelor’s degree in a Mechanical OR Biomedical engineering OR equivalent work experience

(Required)

• A minimum of 3+ years of related work experience in the medical device field (Required)
• Demonstrated skills in managing medical device development projects to produce effective and

differentiated products meeting customer expectations and internal business goals (Required)

• Must have experience working through all aspects of medical device design/development

including design V&V and process validation/technology transfer (Required)

• Working knowledge of design controls regulatory requirements (US, EU, Other) and experience

defending product information or processes in a regulatory audit preferred

• Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility,

Verification) using a risk-based approach compliant with 21CFR/ISO-13485

• Extensive knowhow in V&V procedures and QA materials: writing protocols and reports
• Familiarity with manufacturing technologies
• Proficient in CAD/Solid works
• Excellent time management and organizational skills
• Outstanding written and oral communication