Position Overview

Bolder Surgical (“Bolder”) is seeking a Manufacturing Supervisor for its growing enterprise. Candidate must be versatile and flexible to work within an entrepreneurial company where you can be counted on to exceed goals successfully and quickly by utilizing strategic agility and negotiation skills effectively.

Roles / Tasks

This position is responsible for the following:

  • Directs, administers, and controls the day-to-day operations and activities within the cleanroom to ensure people and resources are applied efficiently and effectively to meet delivery requirements while achieving quality and safety standards (90% or more of the workday to be in the cleanroom providing support to the production assemblers)
  • Assisting in the recruitment and onboarding of new hires
  • Performance management of employees (coaching, counseling, mentoring, disciplinary)
  • Ensure that self and team members follow defined manufacturing procedures and comply with quality requirements
  • Ensure achievement of production throughput against stated capacity targets
  • Trains new employees to manufacturing procedures and ensures training of assemblers is current, including promoting cross-training and cross efficiency in all workflow paths
  • Monitor change over and/or line set up efficiency
  • Tracking of first-pass yield and device scrapping
  • Manage work order closures and stock control transactions to include recording scrap and material usage transactions
  • Creates work orders in designated systems to ensure no disruption to production (to include printing and filling in Lot History Record (LHR) packets, printing and verifying production labels)
  • Ensure all records are completed appropriately and meet Good Documentation Practice (GDP) requirements
  • Primary contact when production issues arise for resolution
  • Initiate investigation of defect devices as needed, escalate appropriately
  • Initiate Non0Conformance Reports (NCR’s) for quality issues and ensure that non-conforming material is clearly identified and segregated
  • Escalation of quality concerns
  • Enable effective communication between management and operators
  • Support assemblers with the final assembly of medical device disposable products in a cleanroom environment
  • Scheduling and managing time off
  • Ensures compliance with established company and regulatory guidelines and procedures to ensure quality standards are met.
  • Follow Safety rules and promote a safe environment.
  • Ensure equipment is within calibration date and all systems are functioning correctly.
  • Lead Problem-Solving events to gain assembler team engagement to identify the root cause and resolve problems to aid in process improvement
  • Complete daily production logs
  • Clean and maintain work area
  • Other duties as assigned.

Requisite Skills

  • Basic reading, writing, and arithmetic skills are required; this is normally acquired through a high school diploma or equivalent.
  • Manual dexterity is required for the assembly of the product and operating computers.
  • Ability to complete required documentation with minimal errors.
  • Ability to flex between one task and another throughout the day.
  • Nice to have: Assembly of electrical devices, Argon welder, medical device experience.

Job Requirements and Qualifications

Education:

  • Bachelor’s degree in business, management, or engineering preferred

Experience:

  • Minimum 3 to 5 years of work experience in a manufacturing environment, preferable in the medical device or other regulated industry, work independently, act as a trainer.
  • Experience in leading a production team, training team members, and performance management of team members.
  • Experience in a startup environment is helpful.
  • Experience with NetSuite is helpful.
  • Microsoft Office (Excel, PowerPoint, etc.)
  • Excellent writing, communication, and interpersonal skills.
  • Reliable, self-motivated team player capable of proactively managing day-to-day responsibilities.
  • Detail-oriented with excellent organizational skills.
  • Ability to interact professionally.
  • Experience in a regulated environment (i.e., FDA) preferred.

Salary Range

$66K-87K (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
  • Employee Assistance Program

Work Environment / Other Information

  • All employees should be vaccinated per CDC guidelines.
  • Ability to work flexible hours.
  • The employee is regularly required to sit, stand, walk, bend, 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 the ability to adjust focus.
  • Ability to pinch and grasp with hands 80% of the time.
  • Ability to work with very small parts (less than a ¼ inch in length).
  • Ability to use tweezers and assemble in small, tight spaces.
  • Ability to use a microscope and magnification tools.
  • Ability to use a variety of hand tools – some require a larger grip (wire crimping tools), and others require fine manipulation (tweezers).
  • Ability to lift or move up to 25 pounds

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.