Global Opportunity with Visa and Relocation _ support based in Costa Rica_, to develop devices that are needed "now" to save lives. Person that can hit the ground running,
R and D Engineer
The Expert Development Engineer will be a high-performing individual that will design and develop medical devices from concept through market introduction. Lead the development of new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
Assures all requirements are met for the Product Development Process (PDP), Risk Management, Design Controls and Usability Testing within technical development concepts, new product development and post market product sustaining. Develops departmental technical policies and procedures, as needed.
The ideal candidate is a self-motivated individual who is excited by the prospect of working in a entrepreneurial environment.
Your responsibilities include:
Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity.
- Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment.
- Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation. Maintains detailed documentation throughout all phases of research and development.
- Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
- Selects techniques to solve complex problems and make sound design recommendations.
- Summarizes, analyzes, and draws conclusions from complex test results.
- Designs and prepares complex reports to communicate results which can be used to discuss with a technical community.
- Designs and coordinates complex engineering tests and experiments.
- Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
- Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
- Translates customer needs into product requirements and design specifications.
- Responsible for engineering documentation.
- May train and/or provide work direction to technicians and entry-level engineers.
- Support internal and external regulatory audits.
What we're looking for in you: EDUCATION & EXPERIENCE REQUIREMENTS
BS in Mechanical / Biomedical Engineering or related field. MS or PhD in Engineering, Physics, or related field preferred.
- 5+ years of medical device design and development from concept through commercialization, experience is required.
- Proven leadership experience working with internal and external constituents.
- Solid understanding of Design for Six Sigma tools and principles
- Design for manufacturability experience.
In depth familiarity with the FDA, ISO, MDD, MDSAP and the medical device industry quality requirements associated with product development, design controls, and product risk management.
Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
Strong communication and presentation skills.
Competent with use of Solid Works, Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
- Depth of knowledge in Endoscopy and Pulmonary as clinical areas
- Depth of knowledge in one or more product areas for Endoscopy and Pulmonary.
SKILLS & ABILITIES
- Demonstrated ability to bring products from concept to market
- Ability to interact with client companies in a professional manner
- Efficiency in the management of resources
- Customer focus with excellent communication skills, written and oral
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit
WORKING CONDITIONS & PHYSICAL DEMANDS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
TRAVEL REQUIRED Estimated: 5-10%
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Job Type: Full-time
- Medical Devices: 3 years (Required)
- Mechanical & Design Engineer: 3 years (Preferred)
- SolidWorks: 3 years (Required)
- Master's Degree (Preferred)
- English (Required)