Candela Corporation Sr. Product Lifecycle Engineer in Marlborough, Massachusetts
Sr. Product Lifecycle Engineer
Requisition Number 2616
Location US - Marlborough, MA
Candela is recognized globally for its innovative energy-based technologies that change lives. Our new brand embodies our continued commitment to innovating medical aesthetic treatment solutions based on solid science and effective outcomes. We aspire to provide the highest levels of clinical, technical, and customer support and continue to build on the longstanding partnerships of trust we’ve established with physicians, their practices, and the patients they treat.
Candidate will be responsible for products that have gone through development and are released to commercialization. The role includes manufacturing support, quality and product improvements, product analysis on field complaints and component obsolescence. As a product engineer in the Life Cycle Engineering group, you will be responsible for implementing the full life cycle of a product developing and implementing a range of solutions for technical product issues working closely with groups from different disciplines. Responsible for problem-solving, identifying design changes, product/process development and demonstrating functionality by building prototypes performing testing and/or analysis and adhering to design control elements to implement into production.
The candidate must have demonstrated ability to troubleshoot, develop root cause analysis and be able to make decisions with minimal direction. The candidate should have product development experience within the medical device industry or other regulated environment, be detail-oriented and organized. This role will interact with other departments and will interact with contract manufacturers regularly and needs to be able to communicate technical updates clearly and concisely.
Essential Job Functions
Design, verify and implement post-market engineer design changes and improvements to commercialized Candela products.
Own post-market engineer projects (Project Technical Lead) from kickoff to implementation.
Engage with cross functional team in pre-market projects (under development) to ensure appropriate knowledge transfer prior to product launch.
Analyze and recommend improvements to production process and methods to facilitate cost reduction and quality improvements.
Problem solver, leads root cause investigations for product performance or process issues and implements changes
Works to maintain product performance and quality of existing products by leading and assisting with issues relating to CAPAs, non-conformances, customer complaints and manufacturing processes.
Creates, updates or supervises designs in CAD, including detailed design of components, tolerance analysis, fundamental calculations, and finite element analysis.
Creates Engineering Change Orders (ECOs) and manages through completion
Research, verify/test and implement replacement of end-of-life components while maintaining the product design intent
Produce DHF and DMR documentation for transfer to manufacturing
Contribute to risk management activities, dFMEA, pFMEA and hazard analysis
Team player who interfaces with different technical disciplines and/or Contract Manufacturers
Performs all duties in compliance with the quality management system.
Bachelor’s degree in Mechanical Electrical, Software or Systems Engineering or other technical discipline with minimum 7 years-experience.
Tenacious problem solver; demonstrated troubleshooting and root cause analysis skills
Effective technical and project lead responsible for project initiation through implementation
Experience with electro-mechanical design
Must be experienced with design and development aspects through all phases of product development
Knowledge of mechanical and/or electronical manufacturing/assembly processes
Possess knowledge of applicable ASTM/ISO standards
Flexible, self-directed, organized, proactive and dependable
Proficiency in SolidWorks and the PDM structure (or a Similar set of tools- Auto CAD, Creo, Pro E, Windchill) - advantage
Requires strong technical writing in support of design inputs, design outputs, qualification activities, regulatory requirements
Periodic travel may be required.
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.
Candela Corporation is proud to be an Equal Employment Opportunity and Affirmative Action Employer and is committed to creating a diverse and inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.