We are looking for an experienced quality engineer to join our Philadelphia suburban location. 

This individual will work with cross-functional engineering teams to ensure consistent compliance with Smithwise’s Quality System and external regulations. The engineer will take an active role in operational tasks including, but not limited to, supply chain and inventory management. The ideal candidate should have 3-5 years of proven experience and track record of implementing quality systems in a medical device development organization.

Smithwise is a contract medical device development firm with offices in the Philadelphia and Boston areas. We work with technology-driven companies to engineer and build electro-mechanical products for medical and consumer wellness applications. Our projects range from IoT wearables to surgical devices to life support systems.  We offer a creative work environment with a highly collaborative team, passionate clients, and technically challenging projects.  Following are the responsibilities and requirements for the position:

Responsibilities

  • Provide input to develop strategies to ensure effective achievement of company quality objectives
  • Responsible for Design Control initiatives to develop appropriate Design History File documents
  • Support development and implementation of Validation & Verification plans and activities
  • Drive Risk Management activities and ensure compliance to standards and regulation
  • Review and approve Design Control documents and protocols
  • Develop and deliver quality assurance and documentation training for organization
  • Manage and support CAPA activities
  • Provide professional, reliable and prompt service to internal and external customers
  • Effectively handle special assignments outside of routine functions

Competencies

  • Work in partnership with others to meet and exceed customer expectations
  • Follow through on customers’ inquiries in a professional and timely manner
  • Interpret customers’ needs and take appropriate action
  • Assure that all verbal and written communications are concise, technically accurate, timely, and professional
  • Demonstrate strong listening, communication, and negotiation skills with a positive, professional, and diplomatic demeanor
  • Respond positively to changing priorities and remain flexible and resilient during stressful situations
  • Adopt new techniques and procedures quickly and employ them into daily job functions

Requirements

  • Bachelor's degree in Life Science or Engineering discipline is required. Other advanced degrees may be advantageous
  • Experience with FDA QSR and ISO 13485 medical device regulations
  • Experience with Risk Analysis tools consistent with ISO 14971
  • Experience with Minitab or similar data analysis package
  • Experience with probability and statistics
  • Familiarity with EN 60601, Safety requirements for medical electrical systems and ISO 62304, Medical Device Software Life Cycle Process
  • Familiarity with US FDA regulations, i.e. 501(k), IDE, PMA
  • Familiarity with OUS regulations, i.e. Medical Device Directive
  • Must be able to move throughout office and laboratory space, using a complete variety of office, inspection, laboratory equipment, and tools
  • Must be able to stand for extended periods of time and use stairs to move between floors
  • Must tolerate exposure to chemicals found in the Smithwise laboratory environment
  • Must be able to lift up to 30 pounds

Compensation

  • Competitive Salary
  • Eligibility for discretionary bonus following 12-months of full-time employment
  • Visit this page for a summary of our benefits including employee out-of-pocket costs
  • Health Insurance of which 60% is paid by Smithwise and the remainder paid by employee pre-tax, eligible immediately
  • Dental Insurance of which 50% is paid by Smithwise and the remainder paid by employee pre-tax, eligible immediately
  • Eligibility after 3 months of employment to participate in simple IRA with dollar-for-dollar employer match up to 3% of salary
  • Company-paid Short- and Long-term Disability Insurance
  • Company-paid Life Insurance Policy (1x Salary)
  • 3 weeks paid vacation. Increase to 4 weeks after 5 calendar years of full-time employment. 8 paid company holidays per year
  • Eligibility for Educational Stipend after 12 months of full-time employment and dedicated time for continued refinement of professional skills

Job Type: Full-time

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Engineering and design role applicants are encouraged to submit a portfolio in addition to a resume.  Portfolios enable our team to understand experience level, skillsets, and design process.  Feel free to provide your portfolio as a link in your cover letter or a combined file with your resume.  Thank you for your time and interest in Smithwise!