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Product Environmental Compliance Engineer in Salt Lake City, UT at Stryker Corporation

Date Posted: 1/30/2019

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Product Environmental Compliance Engineer to join our Neurovascular division in either Fremont, CA, Salt Lake City, UT or Cork, IR.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
  • Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

What you will do

As the Product Environmental Compliance Engineer; you will evaluate regulations and make recommendations as necessary for maintaining compliance with product environmental regulations specific to medical device materials. You will support new product development, new business development (acquisitions), and changes to existing product and ensure compliance by completing thorough assessments and completing the appropriate documentation pertaining to product material environmental compliance.

  • Operate with some latitude for independent action or decision, and reviews progress with management.
  • Provide guidance and input into the work of other cross-functional resources within regulatory affairs, product engineering, technical publications and operations.
  • Provide guidance and input to management, highlighting emerging product environmental regulations and formulating guidance in partnership with engineering resources to charter initiatives for compliance.
  • Responsible for the product environmental compliance process, database and supplier relationship as the Divisional Process Owner.
  • Manage Product Environmental Compliance business process, including process maps and procedures.
  • Report observations/ problems clearly and concisely and takes appropriate actions.
  • Demonstrate developing of advanced technical leadership skills within the department.
  • Possess and apply a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
  • Demonstrate strong project management, writing, coordination, and execution of environmental compliance tasks, with emphasis on technical activities.
  • Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.
  • Plan, conduct and execute assignments, reviewing progress and evaluating results
  • Review of environmental standards and regulations.
  • Conduct gap assessments to new and existing standards.
  • Ensure that all new products are assessed for potential environmental hazards and recommend necessary improvements prior to appropriate design phases per the written procedures.
  • Review and sign change control documents directly related to product environmental controls and assist Regulatory with change management assessments.
  • Write project charters
  • Present and provides direction to management and potentially executive leadership
  • Assist in SOP development and review
  • Assist in the development and update of strategy based upon regulation and standard changes
  • Provide input to new product development and product lifecycle planning
  • Evaluate regulatory impact of proposed changes to launched products
  • Demonstrate understanding and ability to investigate and evaluate updates and new regulations 
  • Determine and communicate environmental requirements and internal processes
  • Ensure compliance with product post-approval or clearance requirements
  • Provide regulatory input for and appropriate follow-up to inspections and audits
  • Assist in the development and implementation of SOPs and systems to track and manage product-associated events
  • Review change management to determine the level of change and potential submission requirements
  • Participate in the development of proposals and solutions to product-associated problems related to ENV Compliance
  • Monitoring impact of changing regulations on submission strategies
  • Identifying issues early in the submission preparation process that could impact product launch

What you need

  • A Bachelor’s Degree (B.S or B.A) in Science, Regulatory or Engineering, or equivalent focus is required.
  • A minimum of 4 years of relevant environmental, regulatory or engineering experience
  • Experience in the medical device or pharmaceutical industry preferred.
  • Previous experience in legal, technical or a regulated environment required.
  • Excellent analytical and writing skills.
  • Excellent interpersonal, written and oral communication skills.
  • Effective organizational skills.
  • Basic PC skills with proficiency in Microsoft office Suite, including Excel.

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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