Position Summary:

The SIL will be responsible for leading medical device projects by guiding cross functional engineering teams in accordance with design controls requirements and practices.

Essential Duties and Responsibilities:

• Coordinate subject matter experts to investigate and address issues during development, verification/validation, and production.
• Ensure compliance with medical device design controls through all design phases.
• Establish and maintain the program and product Design History File.
• Lead Technical Design Review meetings to document and resolve technical issues, as well as Phase/Gate Design Reviews to document program progress through the design control process.
• Develop comprehensive program plans, which identify objectives, risks/risk mitigation, effort estimates and schedule for new product development.
• Develop plans with core members to eliminate and/or mitigate risk. If risks cannot be mitigated within the core team, determine appropriate means to communicate and elevate issues to appropriate individuals within the organization.
• Facilitate core team meetings and issue agendas and minutes. Track progress against the project schedule, deliverables list, regulatory requirements, and action items.
• Resolve conflicts within and outside the team.
• Estimate project levels of effort and resource requirements, working with appropriate staff to understand scope of effort.
• Prepare project plans, schedules, and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Plan and organize project assignments; initiate or maintain schedule for projects and project milestones.
• Follow Product Life-Cycle Management procedure with well documented information to complete Design History File.

Qualifications:

Required education and experience:

• Bachelor’s degree in engineering, project/program management or related field.
• 3+ years of experience in Medical Device Project Management or similar functional role.

Knowledge, Skills and Abilities:

• Excellent verbal and written communication skills.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with Microsoft Office Suite or related software.
• Ability to multi-task in an environment of competing priorities.
• Proven track record of leading effective collaboration in complex group/team environments.
• Actively mediates and encourages team discussion and debate.
• Gains cooperation and commitment from people through influence and indirect leadership.
• Actively seeks collaboration and builds relationships with internal customers and partners to improve overall outcomes.
• Actively listens to customers and uses their understanding of customer needs as the basis for decision making and organizational action.
• Drives and motivates cross functional teams towards successful and timely project completion.
• Build effective teams, instilling a culture of accountability.
• Effectively copes with change and ambiguity as business needs change- demonstrating flexibility while ensuring compliance.
• Makes timely, sound decisions under conditions of uncertainty.
• Experience with regulatory compliance within the FDA and EU MDR.
• PMP certification is a plus.

Physical Requirements:

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

Travel:

10% of travel time expected for the position, overnight, within US

Equal Employment Opportunity:

Spectral MD, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state or local laws.