Sr R/D Engineer
Bedford, MA 01730 US
The Cardiac Ablation Solutions division in searching for a dynamic Senior R&D Engineer to join our growing team! The chosen candidate will be heavily involved in supporting the design work for a critical ablation program. Cardiac Ablation Solutions team is engaged in developing next generation medical technologies that save lives and improves the quality of living for millions of patients across the world.
Responsibilities may include the following and other duties may be assigned.
- Leads the design, development, and implementation of manufacturing line transfers.
- Supports the lead engineer with the overall short-term and long-term design strategy.
- Accountable for supporting day-to-day requests from operations.
- Leads and conducts root cause investigations for manufacturing failures with cross-functional teams.
- Work with other engineers and technicians to execute experimental designs and analysis.
- Ensure execution of detailed engineering analyses & documentation to support design development and support process transfer.
- Assume responsibility as subject matter expert to represent organization as primary contact for specific projects and initiatives.
- Apply and interpret characterization DOE models to establish optimal material and process input set points.
- Communicate effectively with cross-functional teams across multiple Medtronic sites to ensure alignment of bigger picture.
- Manage multiple high priority design requests.
- Utilize technical skills associated with Six Sigma, Lean, DRM/DFSS and other appropriate continuous improvement techniques.
Must Have: Minimum Requirements
- Bachelor’s degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
- 10+ Years design experience in medical device industry, Class III experience helpful, but not required
- 5+ years of experience supporting new product development activities in medical device
- • Ability to work with department peers and middle-management within the marketing, engineering, and manufacturing functional groups.
- DRM knowledge and experience
- Lead and Catheter Design
Nice To Have
- 1. Experience supporting, coordinating and / or leading projects
- 2. Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA)
- 3. Experience in development of new or existing medical devices
- 4. Knowledge of industry standards (ISO 13485) and regulations, specifically EU MDR and UKCA
- Data Analysis
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