Full-Time

Hardware Compliance Engineer

Posted on 11/18/2024

Formlabs

Formlabs

501-1,000 employees

Advanced 3D printing solutions for dentistry

Industrial & Manufacturing
Healthcare

Mid

Cambridge, MA, USA

10% domestic travel required.

Category
Hardware Engineering
Hardware Validation & Testing
Requirements
  • Bachelor’s degree, or foreign equivalent in Electrical Engineering, Engineering, or a related field of study and three years of experience in the job offered or a related occupation.
  • Must have three years of experience in each of the following skills: consumer or industrial electronics product familiarity; hands-on experience with electronics, firmware, or software; familiarity with international hardware standards including those for Safety; working with international manufacturing partners; familiar with the hardware safety certification process; and working with compliance test labs and certification bodies.
Responsibilities
  • Leverage a core knowledge of industrial product regulations to identify relevant standards, translate guidelines into engineering requirements and review product designs for compliance.
  • Employ strong analytical, organizational and communication skills to define testing requirements, assess risk, manage design documents, oversee test lab activities, and communicate project status across engineering, regulatory agencies, sales partners, manufacturing, and senior leadership.
  • Deep involvement and hands on product solution/modification to mitigate EMC/Safety/Other problems found during verification and reviews.
  • Sample setup preparation for both electronic and firmware components.
  • Shepherd new products through compliance assessments, product testing, certification processes and design updates for user safety and regulatory compliance.
  • Work on international approval projects to support Formlabs expanding in new international markets.
  • Maintain compliance of released products and update certifications as regulations change.
  • Prepare regulatory documents and submit them to agencies and third-party service providers.
  • Partner with the Regulatory Compliance Manager and adjacent compliance functions to enhance processes and systems to be more predictive, lean, and expedient.
  • 10% domestic travel required.

Formlabs specializes in 3D printing solutions specifically designed for the dental industry. Their main product, the Form 3B printer, is recognized for its speed, accuracy, and user-friendly operation, making it suitable for both chairside and laboratory use. The printers work by using advanced technology to create precise dental models and appliances from proprietary resins, allowing dental professionals to fabricate items in-house efficiently. What sets Formlabs apart from competitors is their focus on the dental sector, providing tailored products and services that streamline workflows and enhance patient care. The goal of Formlabs is to improve the efficiency and effectiveness of dental practices by offering high-quality 3D printing solutions that reduce costs and improve patient outcomes.

Company Stage

Series E

Total Funding

$246.8M

Headquarters

Somerville, Massachusetts

Founded

2011

Growth & Insights
Headcount

6 month growth

-7%

1 year growth

-11%

2 year growth

-11%
Simplify Jobs

Simplify's Take

What believers are saying

  • Formlabs' rapid innovation, exemplified by the Form 4, offers employees the chance to work on cutting-edge technology that is transforming the 3D printing industry.
  • The company's strong financial backing, including a $150 million Series E led by SoftBank, ensures stability and resources for continued growth and development.
  • Formlabs' leadership in diverse applications, from dental to industrial manufacturing, provides employees with opportunities to impact multiple high-growth industries.

What critics are saying

  • The competitive landscape in 3D printing is intense, with numerous players vying for market share, which could pressure Formlabs to continuously innovate.
  • Rapid expansion and acquisitions, such as that of Micronics, may pose integration challenges and strain resources.

What makes Formlabs unique

  • Formlabs' acquisition of Micronics enhances its capabilities in SLS 3D printing, setting it apart in the market for accessible and advanced 3D printing solutions.
  • The launch of the Form 4, with its proprietary Low Force Display™ (LFD) print engine, positions Formlabs as a leader in speed and reliability for professional 3D printing.
  • Formlabs' extensive library of industry-leading resins and automated post-processing solutions provide a comprehensive ecosystem that few competitors can match.

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Benefits

Flexible vacation

Premium coverage for medical, dental, and vision plans

Paid parental leave

Commuter benefits

Unlimited 3D prints