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Systems Engineer 2

Westford, MA 01886, USA Req #1100
Wednesday, September 6, 2023

Cynosure is well positioned competitively to lead and transform the medical aesthetics industry.  We are guided by our belief that this is a purpose-driven business, which improves patient’s lives and improves practitioner’s livelihoods.

 

  • We are passionate about driving a healthy and growing medical aesthetics industry with leading-edge marketing which inspires consumers to engage in medical aesthetics.
  • We are the leader in science-based technology which elevates the standard of care for consumers.
  • We are relentlessly focused on being the undisputed innovation leader, addressing the growing demand for consumer treatments across all demographics.
  • We are committed to building and strengthening our unmatched global footprint, with direct employees on five continents and in 15 countries and growing, and distributor partners serving over 130 countries.
  • We put our people first and believe personal development drives business development.
  • We love our customers and strive give them the leading-edge technology, service, marketing support and clinical education to improve their patient’s outcomes and to improve their livelihoods.

 

At Cynosure, we look for people who make an impact and encourage everyone to lead, create, and add value. In turn, we invest in our team to grow people’s careers and build upon our high-performance and culture-oriented organization. We work together as one team, winning together.

As we grow our global team, there is no better time to join us. As a market leader in medical aesthetics, Cynosure has over 25 years developing, manufacturing, and marketing products for dermatologists, plastic surgeons, medical spas, and healthcare practitioners. With the aesthetic industry’s most comprehensive product portfolio, our offerings span several categories including skin revitalization, body contouring, hair removal, and women’s health.  

Our mission is to set Cynosure customers up for success shaping future leaders of the aesthetics industry and helping everyone who uses our technologies discover their version of beautiful.

Learn more about us by following our LinkedIn and Instagram sites and please visit us at www.Cynosure.com

Job Summary

Responsible to provide systems level technical expertise in a cross functional product development environment.  In this highly visible and important role, you will lead the system level design of products from concept through design/verification, launch and commercialization support. 

 

Essential Duties and Responsibilities

  • Collaborate with Program Management and Marketing to collect information from cross functional stake holders (Engineering, Marketing, Operations, Quality, Regulatory, Clinical, Service) to define user needs for new product concepts.  This may include the following:
    • Conduct internal and external studies to evaluate new techniques, lasers, or other technologies.
    • Analyze and evaluate data from both in-house and external collaborators to document development.
    • Develop prototypes systems to be used in future evaluations.
    • Responsible for written reports, white papers, patent disclosure, and other publications as part of the development process.
    • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
    • Exercises judgement in selecting methods, techniques and evaluation criteria for obtaining results.
  • Translate high level user needs into Product Requirement Specifications and architecture plans that will serve as foundations for the engineering team (electrical, software, mechanical, optics).
    • Where appropriate and in-line with candidate’s education and prior experience, develop and implement design solutions which address Product Requirements
  • Lead the creation of verification and validation protocols.  Work with project team to assure execution of plans, mitigation of test failures or required protocol deviations.  Ultimately release the final product verification and validation reports.
  • Assure product objectives are met in the areas of functionality, product quality, reliability, serviceability, manufacturability, compliance, and cost.
  • Key deliverables include Product Requirement spec, traceability, system architecture, FMEA, system verification and validation, and ongoing technical support to operations and service.
  • Work with development team to create technical schedule & milestones, while working with Program Management to keep overall project on time and budget.
  • Identify and mitigate constraints and trade-offs relative to product requirements. 
  • Work with hardware and software engineering to assure seamless system integration.  
  • Effectively work with operations, test engineering, quality and service teams to set and achieve DFM and DFS goals. 
  • Manage the document configuration management process (pre-launch BOM, family tree, change requests and rev control, proto-part traceability, design freeze)
  • Organize and conduct system level design reviews.
  • Work with Program Management to effectively transfer new products from Engineering to Operations
  • Collaborate with engineering team and operations during material procurement phases for prototypes and pilot runs.
  • Lead engineering support activities for post launch CIP opportunities.
  • Work with Program Manager and Engineering to create and maintain the DHF to assure compliance with company, FDA and ISO design control requirements.
  • Adhere to defined development processes and procedures.
  • Embody and live our company Values.

 

Qualifications 

Education
Bachelor’s degree required

Master’s degree preferred

Specific Area of Study: BS in an Engineering discipline. Biomedical Engineering degree a plus.

 

Experience

  2 to 5 years relevant experience

Specific Related Experience: Experience in a product development role and demonstrated hands-on experience in the following:

    • Translating user needs into system level specs and architecture.
    • Development, execution and reporting of engineering verification and validation protocols.
    •  Development of complex software controlled electro-mechanical energy-based systems.

 

Skills

  • Experience working in a capital equipment Class II Medical Device design and development environment.
  • High level of familiarity with FDA QMS, ISO13485 Quality Systems, IEC 60601-1 System Safety, IEC 62304 Software Development and ISO 14971 Risk Management.
  • Seasoned technical leader with strong organizational and interpersonal skills.
  • Able to adapt communication style to resonate with intended audience.
  • Ability to see challenges as opportunities.
  • Perseveres in the face of technical or interpersonal challenge; thrives on finding solutions.
  • Coaches and motivates others to find solutions rather than telling them what to do.  
  • Proficient problem-solving skills.
  • Generates high-quality work products and demonstrates good design practices.
  • Demonstrates a consistent and gut-level sense of urgency but remains calm under pressure.

Cynosure is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Other details

  • Job Family Engineering
  • Job Function Systems Engineering
  • Pay Type Salary
  • Employment Indicator Regular
  • Min Hiring Rate $70,100.00
  • Max Hiring Rate $109,000.00
  • Travel Required No
  • Required Education Bachelor’s Degree
Location on Google Maps
  • Westford, MA 01886, USA