Job Description: Job ID: MAM000634
In December 2014, Devicor Medical Products, Inc. was acquired by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in anatomic pathology solutions and automation, striving to advance cancer diagnostics to improve patients' lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer.
Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. Mammotome remains committed to its heritage of advancing technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast care information for patients.
Devicor Medical Products, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.
The Standards and Compliance Engineer is responsible for supporting and executing processes and activities required to certify new and existing products, to ensure compliance in all markets in which Devicor Medical Products, Inc. does business. The Standards and Compliance Engineer works closely with QRA and Engineering to ensure compliance to global standards, codes & technical regulations. This position will support all Devicor Medical Products, Inc. devices and product lines.
Works with Engineering, QRA and external Certification Bodies, to assure that products are designed to meet all applicable international and domestic standards, codes and technical regulations.
Identifies and reviews new or modified standards determine applicability and impact to our products.
Performs gap analysis for all new or modified international and domestic standards, codes and technical regulations.
Ensures that changes in international and domestic standards, codes and technical regulations are broadly communicated and that internal processes comply with those changes.
Resolves compliance issues by working collaboratively across the organization and with external Certification Bodies.
Develops, communicates and manages certification strategies for new and existing product designs.
Develops and publishes internal reports and communications on compliance activities.
Establishes and maintains effective working relationships with various certifying agencies and testing laboratories.
Supports the continuous improvement of certification and compliance tools and processes.
Ensures accuracy of certification records throughout a products lifecycle.
Advises Engineering of design options and impact of design decisions related to product compliance.
Manages all required reporting to agencies assuring they are timely and accurate.
Reviews user documentation to ensure that required warnings, labels and symbols meet all applicable standards, codes and technical regulations.
Works collaboratively with Engineering to create and manage design history files so that they adequately demonstrate product compliance.
Reviews, modifies and prepares the following for compliance activities: Test Report Forms, Design History File documentation, Risk Management Files, Product Configurations, and Labeling.
Works collaboratively with teams to develop, coordinate and document the execution of testing as required for compliance.
Creating/revising risk management documentation.
CRITICAL SUCCESS FACTORS
Communication Communicates effectively at all levels of the organization. Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others. Communicates and listens effectively in order to develop and maintain key business relationships.
Interpersonal Skills Ability to work with co-workers and customers, both internal and external, of all levels. Ability to professionally interact and build constructive and effective relationships with all levels and functions within the Company. Ability to effectively interface with others on behalf of the organization. Influences key business partners and customers to achieve mutually beneficial results.
Presentation Skills Demonstrated ability to present 1:1 or in group settings. Delivers a clear and compelling message tailored to the needs of the audience.
Initiative Ability to work well independently and exercise appropriate judgment under general direction. Ability to prioritize workload, goals and tasks consistent with the department and corporate objectives. Ability to take direction from multiple sources and manage conflicting priorities in an effective and efficient manner. Ability to multi-task, completing concurrent projects within given time frames and managing interruptions and change requests. Takes initiative to establish new processes and methods to support a variety of coordination activities.
Problem Solving Uses rigorous logic to solve problems. Probes all sources for answers. Looks beyond the obvious. Enjoys solving tactical and process problems. Applies appropriate theory and principles, expert judgment, and cross-functional expertise to address a broad range of complex problems.
Decision Making Makes timely, sound decisions based on analysis, wisdom, experience and judgment. Utilizes a high degree of creativity and latitude. Relies on extensive experience and good judgment to ensure that expectations are met and that business objectives are achieved.
Adaptability Embraces and adapts to change and demonstrates a willingness to learn. Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances. Ability to respond quickly to change, and to prioritize actions to meet customer needs.
Trust and Integrity Interacts with others in a way that gives them confidence in one's intentions and those of the organization. Accepts responsibility for one's own decisions and actions. Demonstrates honesty. Keeps commitments. Behaves in a consistent manner and is open, honest and trustworthy.
Global/Business Perspective Shows understanding of issues relevant to organization. Keeps up to date with current practices and trends. Has and uses cross-functional knowledge. Strong grasp of business concepts and related issues.
Negotiation/Influence Ability to persuade others. Builds consensus and gains cooperation from others to obtain information and accomplish goals.
Analytical Skills Strong analytical skills. Identifies and understands relevant trends, opportunities, needs and market direction within the medical device industry. Proven ability to analyze and interpret data, to provide guidance, data driven decisions and recommendations.
Equivalent of 10 years work experience in a medical device design/manufacturing environment working under FDA and/or ISO regulations.
Experience with the application of IEC 60601 and ISO standards for medical devices and/or industrial applications.
Knowledge of risk management process (ISO 14971) and quality management process (ISO 13485) for medical devices.
Experience working directly with external Certification Bodies.
Experience developing compliance and certification strategies.
Experience working with China FDA (NMPA) regulations and other international regulatory bodies.
Experience applying and monitoring RoHS, REACH, and WEEE for products.
Experience applying ISO 11607 and other packaging standards.
10% travel with a mix of domestic and international locations.
Typical work related travel assignments range 3-5 days, and as such overnight, out-of-town stays are required.
PHYSICAL DEMANDS & WORKING ENVIRONMENT
The physical demands and work environment characteristics 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.
Physical demands: While performing the duties of this job, the employee is occasionally required to walk, sit, stand, use hand to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance, stoop, bend, talk and hear.
The employee must occasionally lift and/or move up to 10 pounds.
The employee may need to work at a computer for a majority of the day.
Specific vision abilities required by the job include close vision and distance vision.
Work environment: While performing the duties of this job, most work is in an office environment setting. Lighting and temperature are adequate. The noise level in the work environment is usually quiet to moderate. May be requested to work overtime and weekends for special program events
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page
Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.