Sr. R&D Sustaining Engineer

Position Summary

The Senior R&D Sustaining Engineer develops innovative interventional urological products and provides engineering support to design and/or process alterations to existing products. 
 
As an integral member of the R&D team, this position is primarily responsible for developing new products and making significant improvements to existing products in the areas of customer features, reliability, and cost. This position requires significant experience in material science, chemistry, design and analysis, product reliability, and design for manufacturability, including high volume production methods.  
 

Principal Responsibilities

•    Spearheading and executing modifications and changes to products currently being marketed to improve and optimize performance.
•    Investigating product design and reliability issues in partnership with other R&D Engineers, Manufacturing Engineers, Quality Engineers, and other cross-functional departments to determine root causes and implement solutions.
•    Leading or assisting in efforts to grow manufacturing/supply chain capacity for products currently being marketed.
•    Develop new products and product concepts using existing and emerging technologies per Design Control requirements.
•    Coordinate Design Change and Process Change activities for the impact on the organization; create evidence-based project proposals in alignment with quality system requirements
•    Support engineering activity required to support products through the commercialized life cycle
•    Design prototypes and feasibility models for proof of concept testing.
•    Design and conduct experiments to establish robust product performance that meets customer requirements.
•    Maintain sufficient and accurate technical records in an engineering notebook per company policies.
•    Prepare project-related documentation.
•    Prepare and manage test protocols and reports.
•    Generate invention disclosures to support patent applications for new technology. 
•    Partner with suppliers to develop new products and components.
•    Partner closely with manufacturing and quality engineers to incorporate design for manufacturability.
•    Support manufacturing new and existing products.
•    Contribute to leadership of design efforts and the verification and validation of new product designs. 
•    Plans and coordinates detailed aspects of engineering work Prepare, Participate in, and Lead, as applicable, Design Reviews.
•    Stay current with technology, practices, and general engineering knowledge related to the R&D Engineer field through seminars, literature, and peer groups.
•    Perform other duties as assigned by supervisor.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
•    Develop design inputs and design outputs for changes to existing product or new distributed product.
•    Complete process validation for processes and products including IQ, OQ, PQ & PPQ.
•    Develop new test methods and/or alter existing test methods
•    Support risk management activities and risk management reviews on existing products.
•    Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.
•    Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.
•    Support regulatory approvals and responses to regulatory questions for existing products.
•    Maintain and supplement design history files that are thorough and accurate for existing product
•    Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary
 

Education / Experience Requirements

•    Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related discipline, or related practical experience
•    At least 8 years of related experience 
•    Master’s Degree preferred.
 

Specialized Skills / Other Requirements

•    Knowledge of biomaterials, chemistry with experience with Non-Animal Stabilized Hyaluronic Acid (NASHA) a plus
•    Strong mechanical design and analysis skills.
•    Proficiency in SolidWorks.
•    Proficiency in all phases of product development including design, implementation, verification, validation, and manufacturing. 
•    Exceptional verbal and written communication skills.
•    Familiarity with ISO 13485, MDD, and FDA QSR.
•    Medical device experience required.
•    Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.
•    Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, stamping, adhesive and thermal bonding and various other processes for medical device fabrication and design is preferred.
•    Self-motivated individual with proven ability to work independently from objectives.
•    Proven problem solving and trouble shooting skills.
•    Experience with quality management systems and medical device regulations.
•    Proven communication skills with cross-functional interaction.

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The pay range for this position at commencement of employment is expected to be between $140,000- $150,000 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.