Director at Augusta Infotech
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Manager - Research & Development - Product Development Engineering - Medical Devices (15-20 yrs)
Hiring, Engineering Manager, R&D with min 5yrs in People Management from Medical Devices background with following skill and expertise.
Major Responsibilities :
- Lead team to drive Medical Device Product Development for Neurovascular therapies and other areas of focus as applicable.
- Closely work with the Product Management team to manage global prototyping and development opportunities.
- Work with CTO group to identify areas to partner for Advanced technology projects, direct resourcing in those areas as needed.
- Work with SMEs and customers to identify development opportunities and drive design development following Design Control methodologies
- Drive Product Development following structured practices like ISO13485, EU/ FDA guidelines, and Quality Management Systems
- Develop high-performance solutions and platforms for our customers that maintain the leadership position in the medical devices market
- Drive Process Development/ Optimization activities for multiple facilities.
- Achieves results by implementing rigorous development and project management processes
- Monitor all business-critical engineering metrics with regular reports to management to show progress toward monthly/quarterly/annual goals.
- Delivers constantly on commitments with the specific focus on Launch on Time.
- Closely works with Product Management, Operations, and Sales to ensure flawless execution of the product development.
- Embraces the Continuing Improvement paradigm and achieves YoY engineering productivity by continuously eliminating waste, improving teams focus and prioritization, upgrading talent/ improving capabilities, and expanding team in India
- Improves customer intimacy of the team. Partners effectively with the sales organization to drive the VoC and the ability of the team to develop the right offering to the customer.
- Empower team to grow and achieve results through supported development and coaching.
- Successfully facilitate transfer and support of new product introduction (NPI) into high volume manufacturing.
- Build future engineering capabilities and reward outstanding performance.
- Model and foster core values and behaviors.
- Drive other business-critical activities as needed
- Bachelors degree (Masters degree preferred) in Mechanical, Materials, or related engineering discipline.
- 15+ years of related Engineering experience with 5+ years in managing teams.
- Professional experience within Medical Device markets, clinical conditions, and knowledge regarding engineering requirements and development process
- Strong understanding of Medical Device Product Development Lifecycle from User Requirements gathering to Transfer to manufacturing.
- Well-versed in Medical Devices development following practices outlined in ISO13485, ISO14971, FDA 21 CFR 820.30
- Ideally experienced in catheters/ minimally invasive surgery products R&D
- Technical skills in developing products for the Medical device market, plastic/ polymer processing, metal processing, electro-mechanical design.
- Familiarity with engineering tools (LDFSS or DMAIC), processes and risk assessment methods (eg FMEA, DOE) and other relevant engineering methodologies
- Excellent motivational skills: a person with the ability to set goals and inspire trust and confidence in team members to achieve the highest standards of performance in a dynamic fast-paced environment, while maintaining a high level of expertise throughout the team.
- Excellent judgment, timely and high-quality decision-making skills
- Excellent interpersonal and influencing skills with the ability to build strong, credible relationships across multiple organization functions, internal, external
- Clear, strategic thinker with the ability to identify, analyze, and solve complex problems.
- LEAN/Six Sigma certification is preferred.
- Project planning and execution skills
CRITICAL EXPERIENCE :
- Proven ability to understand and break down clinical needs to manageable engineering tasks and execute on engineering deliverables; collaborate with global teams to successfully deliver on commitments to the business and customers
- Strong customer service mindset and mentality of delivering quality medical device products on time and within company cost and profitability objectives.
- Fluent communication skills facilitating collaboration with own team, customers, internal business leaders, and technology leaders to create value.
- Global experience. Skilled leader in communicating across a global organization with international teams, and excellent at working with different cultures.
MOTIVATIONAL/CULTURAL FIT :
- Innovation demeanor
- Passion for technology
- Self-driven and result-oriented
- Enjoys working in a global matrix environment