Position Overview

Bolder Surgical is seeking a Sr. Quality Engineer possessing technical judgment and the value of understanding customer focus to support the company. Essential that the candidate possesses the ability to drive for results and collaborate on multidisciplinary product development teams from concept to production. The candidate must be versatile and flexible to work within an entrepreneurial environment.

Additionally, this individual should have the ability to:

Additionally, this individual should have the ability to:

  • Apply broad knowledge of principles and practices in a specific practice area.
  • Independently evaluate, select, and adapt standard techniques, procedures, and criteria.
  • Acquire general knowledge of principles and practices of related fields, and ability to function on multidisciplinary teams.
  • Work on multiple projects of moderate size or portions of major projects.
  • Independently apply extensive and diversified knowledge of principles and practices in broad areas of assignments and related fields.
  • Use advanced techniques in the modification or extension of theories and practices of sciences and disciplines to complete assignments.
  • Works on major project or several projects of moderate scope with complex features.

Roles / Tasks

This position is responsible for performing the following tasks upon receiving general direction on key objectives and guidance when necessary, on unconventional or complex problems:

  • Design a complete project, system, component, or process.
  • Prepare complete project documents.
  • Design and conduct experiments and analyze and interpret data.
  • Formulate and solve problems.
  • Review complete project documents for conformity and quality assurance.
  • Develop new techniques and/or improved processes, materials, or products.
  • Assist upper-level management and staff as a technical specialist or advisor.

This position may assign tasks to and direct engineers, technicians, and administrative staff and must possess the following skills:

  • Interacts with Suppliers, customers, contractors, and others.
  • Attends project meetings presents specific aspects of engineering assignments and future actions to be taken.
  • Possesses advanced oral and written communication skills.
  • Represents the organization in communications and conferences pertaining to broad aspects of engineering assignments.

Position specific:

  • Oversee Material control management including receiving, receiving inspection, non-conforming materials, LHR/document review for final product release, sterilization, and material evaluation and disposition.
  • Coordination with the Microbiology Team of ongoing management of environmental monitoring, sterilization requalification, and product bioburden monitoring programs.
  • Quality inspection plan (QIP) development and non-conforming material investigation.
  • Development of calibration and preventive maintenance plans for receiving inspection equipment.
  • Development, review and approval of documentation and records, including QMS updates, rework procedures, deviations, change orders, process validation documentation (MVPs, IQ, OQ, PQ, gage R&Rs and pFMEAs) and quality planning.
  • Works in collaboration with the Supplier Quality Team to establish supplier control plans, resolve quality issues, implement corrective actions, and drive supplier quality improvements.
  • Represent Bolder Surgical as a production quality SME representative for audits.
  • Develop and implement improvement projects.
  • Fluency in ISO 13485:2016 and 21 CFR 820.

Job Requirements and Qualifications

Education: Bachelor’s degree in Engineering or scientific degree.

Expertise:

  • 5+ years Quality Engineering experience.

Salary Range

75K – 120K, (Salary to be determined by the applicant’s education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.)

Company Benefits

  • Medical, Dental, Vision
  • Life and Disability insurances
  • Paid Time Off and Paid Holidays
  • Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
  • 401K retirement savings plan
  • Parental Leave
  • Voluntary Life Insurance for employees, spouses, and children
  • Voluntary Critical Care and Accident Insurances for employees, spouses, and children
  • Tuition Reimbursement
  • Referral reward bonuses
  • Corporate discounts

Work Environment / Other Information

  • Ability to work flexible hours.
  • The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk and hear.  Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
  • Ability to lift or move up to 25 pounds
  • Travel for this position is anticipated to be 8-10 times per year to/from contract manufacturers.

Company Overview

Bolder Surgical was founded with the mission to elevate surgical expectations. Leveraging expertise in energy delivery and precision surgical devices, the company delivers solutions to give surgeons options they’ve never had, optimizing workflow while allowing for minimal surgical impact on every patient. Bolder Surgical has reinvented vessel sealing with CoolSeal, continuing the company’s legacy of innovation.  Bolder Surgical was the first and only company to acquire FDA clearance for a 3 mm pediatric vessel sealer, and its mechanical stapler is the only 5 mm stapler on the market.  Manufactured in the US, Bolder Surgical’s products have been adopted at hundreds of hospitals throughout the world.

Send your resume and inquiries to Bolder Surgical by using the form located here.