Senior R&D Engineer

Position Summary

The Senior R&D Engineer plays a key role in the conception and development of innovative surgical products while leading project core teams through Design History File generation and commercialization activities. As a technical leader, the Sr. R&D engineer will work with project management to appropriately plan, de-risk, and execute projects. The ideal candidate will be internally motivated and personally accountable to project success. They will also enjoy learning from and teaching others in the department to strengthen oneself and continue to improve the abilities of others on the team. The ability to work in a cross functional environment and gather needed information from other functions are critical skills to be successful in this position. 

Principal Responsibilities

FRONT END DEVELOPMENT 

Basic understanding of market research. 

Demonstrate an intermediate proficiency in voice of customer (VOC) translation, surgical procedure knowledge, and competitive landscape knowledge. 

CONCEPT GENERATION 

Demonstrate an advanced proficiency in solid modeling, prototype and breadboard development and creating concepts to meet requirements. 

Demonstrate an intermediate proficiency in usability testing and UX informed design. 

INTELLECTUAL PROPERTY 

Demonstrate an intermediate proficiency in general knowledge of patents and interpretation of claims. 

Demonstrate a beginner proficiency in patent strategy (offensive, defensive, etc). 

MECHANICAL ANALYSIS 

Demonstrate an advanced proficiency in statics (free body diagrams), stress/strain predictive analysis, material property knowledge, test method development, failure analysis, and tolerance analysis. 

Demonstrate an intermediate proficiency in design and feailure analysis via finite element analysis (FEA). 

DESIGN CONTROLS 

Demonstrate an expert proficiency for technical documentation following GDP practices. 

Demonstrate an advanced proficiency for generating technical drawings while applying applicable standards to dimensioning and tolerancing. 

Demonstrate an advanced proficiency for qualification/verification planning 

DESIGN FOR MANUFACTURING & ASSEMBLY (DFx) 

Demonstrate an advanced proficiency in DFx principles, component qualification, product validations, and process validations. 

RISK MANAGEMENT 

Demonstrate advanced proficiency in FMEAs. 

REGULATORY 

Demonstrate intermediate proficiency in familiarity with regulatory requirements, standards, and guidances for design controls and risk management. 

DATA ANALYSIS 

Demonstrate advanced proficiency in statistical analyses including: normality testing, probability distributions, comparison of means, process/design capability validation, and non-parametric data. 

LEADERSHIP 

Demonstrate advanced proficiency in teamwork/ 

Education / Experience Requirements

• Bachelor’s degree in Engineering or related discipline required, Mechanical/Biomedical (mechanical) Engineering preferred 
• Minimum of eight (8) years relevant engineering experience in a regulated industry required, medical device experience strongly preferred. Experience designing components within a medical device facility utilizing CAD software preferred 

Specialized Skills / Other Requirements

• Proficiency with Solidworks required. 
• Familiarity with various materials and processes, such as extrusion processing, injection molding, machining operations, fixture and tooling development, and adhesive and thermal bonding techniques 
• Experience in project management, documentation, and a working knowledge of quality systems and medical device regulations (ISO13485). 
• Working knowledge and application of ASME Y14.5-2009 Dimensioning and Tolerancing for Engineering Drawings. 
• Self-starter with strong proactive work ethic, well-organized and detail-oriented. 

TRAVEL REQUIRED: 20% 

 
The pay range for this position at commencement of employment is expected to be between $120,000- $140,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.