Product Regulatory and Reliability Engineer

Leer, Inc.

$75K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Mechanical, Electrical, or Industrial Engineering; Master's is a plus.
  • 3+ years experience in product regulatory affairs or reliability engineering.
  • Experience with certifications like UL, CE, and ISO.
  • Familiarity with global regulatory requirements, especially in North America and Europe.
  • Proven track record in conducting reliability tests such as HALT or HASS.
  • Certified Reliability Engineer (CRE) preferred.
  • Strong skills in statistical analysis and applicability of reliability methodologies.

Responsibilities

  • Lead development and submission of global product regulatory documentation.
  • Ensure compliance by coordinating product testing and certifications.
  • Collaborate with regulatory agencies to facilitate approvals.
  • Develop and execute reliability test plans for new products.
  • Conduct failure mode analysis to identify product weaknesses.
  • Monitor field performance data to proactively address reliability issues.
  • Drive continuous improvement of product compliance and reliability metrics.

Benefits

  • Employee Stock Ownership Plan (ESOP) for company ownership.
  • Annual bonus program.
  • 3 weeks paid time off starting in the first year.
  • 11 paid holidays each year.
  • Subsidized health, dental, and vision insurance.
  • Paid short-term and long-term disability insurance.
  • 401(K) retirement savings plan.
  • Shoe stipend for steel-toed footwear.
  • Cares Program offering fitness equipment discounts.
  • Community service involvement hours.
Full Job Description
Summary

The Product Regulatory and Reliability Engineer will be responsible for ensuring that Leer products comply with applicable regulatory requirements and meet the highest reliability standards throughout their lifecycle. The role will involve working closely with product development teams, regulatory agencies, and suppliers to ensure all products adhere to safety, performance, and regulatory standards. Additionally, the Product Regulatory and Reliability Engineer will be tasked with identifying and mitigating reliability risks, driving product improvement initiatives, and conducting failure analysis to enhance overall product performance and durability.

Essential Duties and Responsibilities

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities as management may deem necessary from time to time.

Regulatory Compliance Administration
  • Lead the development and submission of North American and global product regulatory documentation and listings, including safety listings (UL, CE, NSF), product performance certification (DOE, NRCAN, NOM, FM), and material compliance (Prop 65, TSCA, PFAS, RoHS, etc).
  • Ensure products meet industry standards and regulations by coordinating testing, certifications, and approvals.
  • Collaborate with external regulatory bodies, agencies, and third-party testing organizations to facilitate approval processes.
  • Complete submission of required annual filings to all applicable agencies.
  • Facilitation of federal, state, and local building code product application reviews for structural testing and requirements related to wind, seismic, snow, and other dynamic loads.
  • Monitor industry trends along with federal, state, and international regulatory landscape to ensure products remain competitive and compliant with evolving standards.


Product Reliability and Risk Management
  • Develop and execute laboratory and field reliability test plans for new products to ensure performance under various conditions (e.g., environmental, thermal, mechanical stress).
  • Conduct failure mode analysis (FMEA, FTA) to identify and mitigate product weaknesses.
  • Work with design and manufacturing teams to recommend design modifications based on test results and reliability analysis.
  • Monitor field performance data and customer feedback to identify trends and potential reliability issues.
  • Identify potential risks in product designs related to safety, regulatory compliance, and reliability, providing mitigation strategies.
  • Conduct risk assessments and ensure reliability standards are integrated into product development processes.
  • Drive continuous improvement in the product development process by identifying opportunities to enhance compliance and reliability metrics.


Cross-Functional Collaboration
  • Work closely with engineering, manufacturing, supply chain, and commercial teams to ensure products are developed and manufactured in compliance with regulatory standards and reliability expectations.
  • Communicate regulatory and reliability concerns to relevant stakeholders, including management and cross-functional teams.
  • Provide training and guidance to engineering teams on regulatory requirements, reliability best practices, and testing protocols.


Documentation and Reporting
  • Maintain thorough records of testing, certifications, regulatory filings, and any changes to product designs or specifications that affect compliance or reliability.
  • Prepare and present regulatory and reliability reports for management, regulatory bodies, and other stakeholders.


Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related field. A Master's degree is a plus.
  • Minimum of 3+ years of experience in product regulatory affairs, reliability engineering, or related roles.
  • Experience with product certifications, including UL, CE, ISO, or similar standards.
  • Familiarity with regulatory requirements in key markets, including North America, Europe, and Asia.
  • Proven experience conducting reliability testing (e.g., accelerated life testing, HALT, HASS).
  • Certified Reliability Engineer (CRE) or other relevant certifications are desirable.
  • Strong understanding of engineering principles, product design, and development processes.
  • Proficient in statistical analysis and reliability methodologies (e.g., FMEA, Weibull analysis, reliability prediction software).
  • Excellent problem-solving and analytical skills.
  • Strong written and verbal communication skills to prepare technical reports and collaborate with cross-functional teams in a team environment.
  • Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment.
  • Superior computer skills and understanding of Microsoft Office programs required.
  • Knowledge of refrigeration systems a plus, but not a requirement.


Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Wear required safety equipment when on shop floor. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand. The employee is occasionally required to walk; sit; and use hands to finger, handle, or touch objects, tools, or controls. Specific vision abilities required by this job include close vision.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

So, what do you get out of working at Leer, Inc. beyond a friendly work environment and the best teammates around? A competitive compensation package that other manufacturers can't beat. Take a look.

ESOP Distributions
  • An ESOP is an Employee Stock Ownership Plan. Like mentioned above, Leer Inc. is 100% employee owned. That means you, as a Sheet Metal Processor, will be an employee-owner and own a piece of the company. Trust us when we say, if you include your yearly ESOP payments, we offer a compensation package that's difficult to beat. Don't believe us? Stop in and we'll show you.
  • Bonus Program
  • Generous Paid Time Off (Starts at 3-Weeks in 1st Full Year)
  • 11 Paid Holidays
  • Health Insurance (Subsidized by Leer)
  • Dental Insurance
  • Vision Insurance
  • Short-Term Disability Insurance (Paid by Leer)
  • Long-Term Disability Insurance (Paid by Leer)
  • Life Insurance (Paid by Leer)
  • 401(K)
  • Shoe stipend for steel toes
  • Leer Gear
  • Cares Program - up to 50% off fitness equipment or gym membership
  • Community involvement hours


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