Senior Product Compliance Engineer

Location:

Michigan City, Indiana, United States

Job ID:

R0052436

Date Posted:

2024-05-17

Company Name:

HITACHI GLOBAL AIR POWER US, LLC

Profession (Job Category):

Engineering & Science

Job Schedule: 

Full time

Remote:

No

Job Description:

Summary of the position:

The Senior Product Compliance Engineer is responsible and accountable for ensuring that products are designed and manufactured in full compliance with all applicable directives, regulations, and legislative requirements, both domestic and international.

This position reports to the Director, Global Product Lifecyle Management, and will involve extensive cross-functional interaction, particularly with engineering, manufacturing, quality, sales, and marketing and at all stages of product development from research and pre-development through to post manufacturing support. The role involves being a key and influential member of the business with the prime focus of ensuring that current and future products are designed and manufactured in full compliance with applicable standards, directives, regulations, and legislative requirements.

Duties and responsibilities:

• Determine regulatory and compliance requirements of new products being developed and engineered orders based on where Hitachi Global Air Power intends to sell the products.
• Verify, review, and maintain all existing and emerging company and Government regulatory policies, standard work and procedures that have been documented, implemented, and communicated.
• Provide training and disseminate written policies and standard work on new and current product development projects to ensure compliance.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and standard work.
• Participate on Standards and Regulatory Committees.
• Assist with and provide technical input into new product and component development for the purposes of ensuring compliance.
• Conduct product safety reviews.
• Work with engineering, manufacturing, and quality engineers to conduct periodic internal audits to ensure compliance with regulations and standard work.
• Conduct or direct the internal investigation of product compliance issues; identify compliance issues that require follow-up or further investigation.
• Serve as a point of contact for communication with management to seek clarification on issues or report irregularities.
• Provide sales support during customer meetings and visits when required.
• Provide technical writing and review of data or reports that will be incorporated into regulatory submissions to assure rigor, accuracy, and clarity.
• Review product promotional materials, labeling, specification sheets or test methods for compliance with applicable regulations and policies.
• File appropriate compliance reports with regulatory agencies.
• Report violations of compliance or regulatory standards to duly authorized enforcement agencies as appropriate or required.
• Prepare and present the Company’s ability to ensure all controls are in place for all product lines.
• Oversee all product certification audits and shall work with other departments to ensure audit success.
• Responsible for working with third-party agencies and government agencies to ensure that products are being certified on time and on budget

Qualifications:

Education:

• Bachelor’s Degree in Mechanical Engineering or Electrical Engineering; Master’s Degree a plus.

Professional experience:

• Minimum of 7-10 years of regulatory compliance experience preferred.
• International Regulation experience a plus.
• Ability to understand Hitachi Global Air Power Portable and Stationary compressor systems.
• Strong blueprint, P&I and Wiring Diagram reading capabilities.
• In-depth knowledge of compressor and other rotating equipment and their subsystems a plus.
• Ability to use relevant information and individual judgment to determine whether products or processes comply with laws, regulations, or standards.
• Leadership skills to guide and train associates on Government regulatory policies and procedures.
• Must have a commercial appreciation with the ability to understand the importance of completing projects on time and to budget.
• Highly computer literate.
• Ability to compose accurate technical and general business documentation to a consistently high level.
• Ability to comfortably and effectively communicate at a high technical level, but also be capable of detailing and explaining complex information in non-technical terms.
• Attention to detail is essential as is a drive to perform tasks properly