Mgr, Systems Engineering

As Manager, Systems Engineering of Peritoneal dialysis department within Renal business, expected to deliver to the department vision that aligns with the organization's vision or strategic plan. Based on significant technical expertise, reviews and approves complex design concepts and provides general direction to technical staff. Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Acknowledged outside of business unit or division for input on programs of some magnitude. Exhibits creativity and innovation in completing divisional and cross-functional/business unit responsibilities.

Role & responsibilities

• Effectively communicate and realize vision and strategy for the organization that aligns with the business and patient needs.
• Ability to lead technical team in the group that ensures clear accountability and operational excellence.
• Ensures that succession planning and talent pipeline is in place for the team members across multiple functions and/or technical disciplines.
• Leverage partnerships effectively with cross functional teams including the business unit, quality, program management, manufacturing, regulatory, medical and clinical to achieve business results.
• Establish processes for effective resource management from planning through execution in close collaboration with program management.
• Foster an environment where mentoring, coaching, career growth and progression, and employee development are critical focus areas.
• Create a culture and environment that attracts, develops, retains, and grows diverse and top talent aligned with organizational strategy.
• Ensure effective performance management.
• Applies knowledge of medical device lifecycle management to effectively drive specific phases of product development and sustainability with high quality and predictability of timeline and budget.
• Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards and ensures appropriate design controls are being adhered to during sustaining engineering efforts and new product development.
• Takes ownership for the continuous improvement initiatives within the assigned function in alignment with business needs.
• Identifies and builds technical competencies and system approach to realize all aspects of product development including innovation/ideation.
• Drives effective collaboration with external partners.
• Lead the development and integration of project System deliverables which may cross several disciplines; evaluate alternatives against agreed criteria. Coach the team to select solutions, assess risks and for understanding full range of implications across the system.
• 
  Review and analyze proposals to determine if benefits derived and possible applications meet quality, cost and performance with future roadmap and sustenance considered.

Qualifications / Experience and/or Background

• Bachelors in Electronics or Electrical or Mechanical Engineering or Computer Science or any other relevant engineering discipline, Masters preferred,
• 12+ years of experience including 2+ yrs of functional leadership experience.
• Must be well versed in engineering disciplines Must possess knowledge of related disciplines.

Knowledge of GMPs, FDA guidelines, purchasing practices and process validation.

• 
  Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
• 
  Ability to manage multiple cross-functional teams simultaneously.
• 
  Ability to design and influence outside of immediate scope of responsibility.
• 
  Maintain industry contacts and be involved in industry interest groups.
• 
  Proven track record of management/leadership effectiveness