Diversity Nexus · 2 months ago
Engineering Program Lead – Regulatory & Compliance Focus (Program Manager)
NY
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expDiversity Nexus is seeking an Engineering Program Lead with a focus on Regulatory & Compliance to manage cross-functional teams in complex engineering assignments. The role involves ensuring compliance with medical device regulations and effective project execution, requiring strong project management and problem-solving skills.
Staffing & Recruiting
Responsibilities
Independently plan, execute, and direct cross-functional engineering projects, adapting standard engineering principles to develop innovative solutions
Manage projects consisting of cross-functional teams (including but not limited to regulatory, risk management, quality, technical communications, and supplier quality)
Oversee all financial aspects of product development, including capital expenditures and cross-functional expenses
Identify and resolve complex problems, developing new solutions as needed for project roadblocks
Qualification
Required
Bachelor's degree in Engineering or a related field
8-10 years of relevant experience in project management, with a focus on medical devices
2-5 years of experience in matrix management
In-depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling and compliance
Familiarity with project management frameworks (e.g., Agile, Waterfall) and tools (e.g., Gantt charts, project management software)
Strong foundation in engineering principles relevant to medical device design and development
Knowledge of QMS practices and documentation requirements
Understanding of the roles and responsibilities of various departments involved in medical device development
Proven ability to manage multiple projects simultaneously, ensuring timely delivery within budget
Strong analytical and problem-solving skills to identify issues and develop effective solutions
Excellent verbal and written communication skills for diverse audiences
Ability to lead and motivate cross-functional teams
Meticulous attention to detail in reviewing labeling documentation
Ability to make informed decisions in evaluating engineering techniques
Flexibility to adapt to changing project requirements and industry trends
Strong organizational skills with effective prioritization
Ability to build and maintain positive working relationships
Commitment to staying current with industry developments
Company
Diversity Nexus
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase