Current Opening: Director of Product Development / R&D
Department: Product Development
We have an exciting opportunity for a Director of Product Development/R&D to join our team! Responsible for engineering activities to develop and commercialize new products while providing sustaining support for current and future commercialized product this role will provide engineering expertise as a senior leadership team member with current product improvements and future product line expansions, develop operating plans and organize top talent to support those plans.
- Actively lead in the generation of requirements interpretation, design descriptions, design specifications, prototypes, system integration, and design verification.
- Oversee the specification, design, documentation and verification / validation through product transfer of electro-mechanical medical device systems. Develop and communicate departmental plans including budget, timeline and goals.
- Research, plan, organize and lead projects through the design control process. Work closely with Marketing and Project Leads to define and manage common design and transfer processes.
- Plan and manage to a commercial project budget, monitoring actual project expenses to budget and department resources; proactively manage budget and variances.
- Manage the Design Control process to ensure it is effective, efficient and produces products that are reliable, provide patient safety and meet regulatory requirements.
- Understand all elements that go into cost of goods sold and in conjunction with Operations, lead phased implementation of design and process updates to achieve cost targets.
- Manage product requirements and testing related to electrical safety, EMI/EMC, transit, shelf-life, biocompatibility, sterilization and product life-time testing.
- Follow appropriate internal quality initiatives including applicable SOPs, Work Instructions and external quality initiatives including FDA regulations and guidance documents.
- Master in Engineering, or equivalent with 7+ years in medical devices
- Experience supervising engineers and technicians to accomplish research goals
- Strong collaborative skills, creative problem solving, keen attention to details and outstanding organizational abilities
- Proven track record of successful leadership developing and launching new products to mar software such as MS Project
- Ability to align and manage multiple projects simultaneously and achieve scheduled milestones; demonstrate risk project management including contingency planning
- Knowledge of FDA Quality Systems, Design Control requirements and ISO 14971 Risk Management and their application to projects from design inception to manufacturing release
- An attention to detail and an ability to absorb and assimilate information rapidly
- Strong team-working and communication skills
- Competent using office software including MS Word, Excel, MS Project, PowerPoint, Solidworks
- Excellent written and oral communication skills, including computer literacy
Duties of this job may involve standing and/or walking, but for most part sitting for extended periods of time. Duties also involve daily keyboard data entry. The noise level in the work environment is usually moderate. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure. While performing the duties of this job, the employee is regularly required to sit.
If you are interested in joining our team, please send your resume to email@example.com.