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Sr. Engineer - R&D Arizona
SUMMARY
This is a high-level research and
development engineering position. It requires a high-energy individual with excellent teamwork, partnering and negotiation
skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on
engineering position that leverages medical device development / quality / manufacturing experience in new product and process
development. Responsible for both the technical aspects of product design and development as well as the translation of marketing
requirements into product specifications.
Excellent verbal and written communication skills, detail orientation
and analytical / problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results
with minimal direction.
Primary Duties- Initiates new or revised documentation and tracks through
appropriate approval cycles and implementation.
- Maintains a professional working relationship
with internal & external customer and support staff.
- Participates and leads cross-functional
teams.
- Provides technical support on components, material methods, systems, and equipment.
- Develops physical and functional test requirements to assure specifications and regulations are met.
- Writes and approves protocols, reports and data.
- Manages testing outlined in protocols
and test methods.
- Manages / develops validation studies on equipment & processes.
- Conduct complains investigations.
- Understands and follows company procedures and regulatory
requirements.
- Participates in and provides input to training on department & division procedures,
and policies.
- Manages project planning, budgeting, scheduling and tracking.
- Plans and coordinates engineering test builds.
- Analyzes problems in design, process
and test development. Recommend / implement solutions.
- Prepares and presents oral and written
project updates and technical discussions.
- Develops and implements procedures / policy.
Experience/Education
Bachelor’s degree in science or mechanical engineering plus four to eight years, (Master’s degree plus
two to six years, or Ph.D. with zero to four years) of engineering experience within the medical device or equivalent industry.
Skills
- Experience as the lead R&D engineer on a medical device product development program.
- Demonstrated proficiency in mechanical design, tolerance stack-up analysis, Design for Manufacturability (DFM), and
specification development.
- Design capability with small plastic and metal parts.
- Demonstrated proficiency with Geometric Dimensioning and Tolerancing GD & T).
- Working
knowledge of nitinol and other materials typically used in medical devices.
- Significant experience
in product verification and validation testing, medical device new product development and rapid prototyping.
- Experience in product verification via test equipment development and equipment validation (IQ / OQ / PQ) within
an FDA regulated or other regulated industry (i.e. bio-tech / pharma, aerospace, food / beverage).
- Clinical
trial and / or animal trial experience.
- Proficient in technical writing of protocols and reports.
- Proven capability in writing clear and detailed testing and product assembly procedures.
- Impeccable
documentation skills and adherence to design control procedures and GLP.
- Demonstrated experience
in application of lean manufacturing principles.
- Comfortable in a dynamic working environment
with a high amount of change.
- Demonstrated ability in using statistical experimental design
and analysis techniques (i.e. Taguchi Design of Experiments).
- Familiarity with Pro-E and / or
FEA software.
- Ability to make and present engineering decisions.
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