We are seeking an experienced, high caliber Senior Mechanical Engineer to design and develop new products and accessories while designing upgrades to existing products. This position requires a mechanical engineer ready to be a team player and support projects from initial concept, through development and verification/validation testing, and into manufacturing. This engineer will use a wide variety of technical skills and reasoning in analyzing mechanical systems (e.g. for stress and strain, wear, or defect), designing mechanical systems, designing and running tests (e.g. mechanical and/or reliability testing), improving or resolving product features, and documenting findings (e.g. protocol test reports, engineering memos). Experience with Spinal Anatomy is strongly preferred as this position requires the engineer to take lead of pre-clinical and support clinical testing of devices.
Impact this role will have on Abbott:
Join the team at Abbott that develops medical devices to manage chronic pain, Parkinson's, and other neurological disorders. Our team produces the leads and implant tools for devices implanted into the brain and epidural space. We change lives and restore hope when it’s lost.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
- Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
- Minimum 5+ years’ experience in medical device related R&D.
- Experience designing and testing mechanical systems.
- Experience leading pre-clinical testing of devices and supporting clinical testing of devices.
- Experience leading design reviews and supporting physician visits.
- Experience with a variety of manufacturing processes and designing for manufacturability.
- Experience supporting projects through verification/validation testing, and ensuring long-term manufacturing readiness.
- Experience with hands-on prototyping, test methods/experiments, and data analyses.
- Ability to lead small teams and to work within large multi-disciplinary teams as an individual contributor in a fast-paced, changing environment.
- Knowledge of documentation requirements for regulatory bodies for Class III devices, and the ability to create that documentation.
- Excellent interpersonal skills are required for satisfying internal customers (e.g. in supporting Marketing, Manufacturing Engineering, Quality)
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Ability to communicate with internal departments and external vendors to obtain prototype parts and to expand these groups’ capabilities.
- Experience designing devices to meet user needs & familiarity with how to generate physician based user needs.
- Experience establishing product requirements and specifications (including justification and supportive testing).
- Experience designing and developing test methods from scratch, running standard mechanical and electromechanical test methods, and documenting results.
- Experience with Test Method Validation and Gage R&R.
- Experience successfully utilizing CAD & analytical design to drive development such as Finite Element Analysis (FEA).
- Experience using experimental, empirical and numerical analysis to evaluate designs.
- Demonstrated ability to identify and mitigate project risks.
- Maintain a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
- Maintain a detailed understanding of Abbott, FDA 21 CFR Part 820 and ISO regulation.
Your preferred qualifications and education:
- Master’s degree in Mechanical Engineering
- Experience with ISO/TS 10974 or MRI safety assessment
- Experience with Solidworks and Winchill
- Experience with Spinal Anatomy
- Experience in polymer processing (injection molding, extrusion, reflow, bonding)
- Experience with non-linear Finite Element Methods
- Experience with Geometric Dimensioning and Tolerancing (GD&T)
- Experience designing and testing small (1-2 mm range) medical devices
- Experience mentoring, and guiding entry level engineers and co-ops with work tasks and successful completion
- Experience with Design for Six Sigma or Quality Function Deployment, and Design for Manufacturability or similar tool set.