"Who we want Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. Dedicated achievers.
Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to design medical devices. User-focused creators.
Engineers who design with the user in mind, developing software that helps change patients’ lives. What you will do The Staff R&D Engineer is responsible for a wide variety of investigative research and new technology/platform development that advances the division’s capabilities and supports the long-term growth strategy. The Staff R&D Engineer provides technical skills, leadership, innovative thinking, and customer focus, while engaging with other divisions and third parties to deliver new technologies and platforms.
In this role, experience of or knowledge in Business Development and Mergers & Acquisitions, (to include remediations), is preferred. The Staff R&D Engineer should also have familiarity with Medical Instrument Technologies The Staff Engineer will focus primarily on Business Development and Merger & Acquisition related activities working cross-functionally to execute new technology/platform development strategies that are aligned with the five-year strategic plan.
This role approaches complex problems with an inquisitive nature—embraces multifaceted inputs to develop comprehensive & creative solutions.
The Staff Engineer plans and leads new technology and platform execution from proof of concept to pilot scale and to market release as applicable, partners with Advanced Operations to facilitate the transfer of new technologies into design specifications and manufacturing processes, collaborates with our Sales and Marketing teams, as well as customers to better understand business and clinical needs, and translate those into value propositions for business investments, supports the alignment of Regulatory and Marketing on product claims and launch strategies and researches and develops novel comprehensive test methods and systems to support diverse technologies and platforms.
The Staff Engineer plans and directs new product development including leading design team activity to perform root cause analysis and modify plans as appropriate. The position leads the development of technical protocols and reports to support technology readiness confidence levels and other project milestones.
They will also sponsor studies with test facility for clinical feedback as applicable and provide leadership in business updates/presentations to management and stakeholders This position will potentially have supervisory responsibilities of interns or R&D technicians for new technology/platform execution and provide leadership and mentor other engineers,What you need
- Bachelor's degree in Mechanical Engineering or Engineering related field.
- 5+ years’ Engineering experience with 2+ years medical device industry required
- 2+ years Business Development and Mergers & Acquisitions experiencepreferred
- Familiarity with Medical Instruments Technologies
- Advanced understanding of Statistical Methods and Project Management Principles (formal training preferred)
- Ability to direct development of an action plan and estimate requirements for resources, (management, tasks, budgets, labor, materials, and time required to complete projects).
- In-depth knowledge of medical terminology/concepts related to medical devices.
- Advanced knowledge of FDA requirements associated with the development of medical devices including Design Control and the technical supportrequired for regulatory submissions..
- Microsoft Word, Excel, Power Point, Outlook, Project, Visio
- Excellent organizational skills and ability to plan/prioritize activities.
- Strong verbal and written communication skills; ability to present issues, plans and objectives.
- Ability to work in fast-paced organization, meeting multiple deadlines and succeeding under pressure is a must.
- Motivated, resourceful, ambitious, enthusiastic and attentive to detail.