This role holds responsibility for the development and execution of Manufacturing functional strategies and deliverables for the products including the establishment of quality, service, productivity and cost objectives. Responsible for the systems, processes, practices, and personnel necessary to deliver products that meet or exceed established quality, delivery and cost targets. Provides Manufacturing Engineering leadership to Operations Representatives and Process Development functions across all phases of development and commercialization of the product family to achieve company objectives.
This role will be expected to proactively identify strategic initiatives to accelerate the successful development and commercialization of the Product family. A dynamic team player and leader who can work effectively on cross-functional teams, while having the strength and understanding to work outside defined functional boundaries when required.
- Responsible for the development and implementation of strategic manufacturing strategies to support the development and commercialization of the family of products.
- Direct responsibility from an Operations standpoint for program design, planning, budgeting, implementation and outcomes through each phase of the PDP cycle (development to commercialization).
- Partner with key internal and external stakeholders to ensure on-time delivery of key milestones and deliverables – R&D, Quality, Regulatory, Supply Chain, Finance and Marketing.
- Develop and implement suitable processes, procedures, and deliverables that guide process development for Engineering and contract manufacturing teams.
- Provide leadership and drive activities to ensure approved AOP programs, capital and expense budgets are achieved.
- Liaise with the leadership team to manage resources, systems, and functions in the advancement of our products
- Facilitate the sharing of technical knowledge and the assignment of technical resources to leverage capabilities across the company.
- Extensive knowledge of the Medical Device industry
- Broad cross-functional experience in Manuf., Supply Chain, R&D, Quality or Regulatory Affairs,
- Bachelor’s degree in a relevant technical discipline required; post-graduate technicalbusiness qualification preferred
- Knowledge of lean sigma principles, qualified to Black Belt level is advantageous
- Minimum of 7 yrs preferably 10+ years experience managing project teams andor functional teams
- Strong influencing and leadership skills essential
- Proven results-driven track record and direct experience driving continuous improvement initiatives
- Excellent team-building, talent development, and communication skills
- Able to collaborate effectively at all levels in a matrix organization
- Strategic thinking with the ability to translate into tactical goals and objectives and effectively lead and engage a multi-disciplinary team in achieving these goals.
- Broad cross-functional experience in Manufacturing, R&D, Process Development, Supply Chain, Quality or Regulatory Affairs
- Proven results-driven track record and direct experience of PDP
- Proven track record in cross-functional collaboration
Skills and Competencies:
- Executes: Takes accountability for and delivers consistent decisions, actions, and results. Aligns team, allowing people to move quickly in a coordinated fashion
- Clear Thinking: Translates complexity into simplicity and articulates crisply and clearly, Creates and communicates a clear strategy/plan, Demonstrates good judgment
- Driven To Win: Passionate and driven, Makes tough decisions in difficult situations, Capacity for work
- Inspires Others: Authentic and sets a vision that inspires performance and engages others, has an infectious enthusiasm, Seeks and values different perspectives and ideas to foster an inclusive work environment
- Boundaryless: Breaks down silos, collaborates across organizational boundaries, Fosters diverse thinking and integration
- Compliance & Integrity: Promotes and practices a culture of integrity, ethics, and compliance with laws and policies. Champions implementation of compliance policies, training, and monitoring programs. Expeditiously takes appropriate actions when problems occur
- Mission Values: Consciously works to bring the Mission alive.
- Strives to continuously improve quality in our people, processes, and products