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Technology Manager - Device Qualification

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Date: 17-Jun-2019

Location: Yangzhou, 32, CN

No Relocation Assistance Offered
# 73596 - Yangzhou, Jiangsu, China

CORE RESPONSIBILITIES:
 Assessment of new and existing Device products against company standards for product performance, safety, quality, and reliability. This includes overseeing reliability test plans and assessments as well as environmental testing
 Ensure new and existing products meet external regulatory and agency compliance requirements.
 Be proficient & oversee different product compliance standards focused on medical device and household electrical device compliance including safety standards IEC 60335, GB4706, UL1310, UL1431; EMI/EMC standards CISPR 14 and FCC Part 15; radio standards China SRRC, US FCC, EU ETSI; environmental regulations RoHS and REACH; and other local electrical device standards such as China CCC/CQC

LEADERSHIP/SUPERVISION:
 Candidate will need to have ability to manage project related tasks with little supervision. This includes managing external consultants and agencies to deliver project requirements and lead post-production activities to support regulatory compliance.


DAY-TO-DAY RESPONSIBILITIES:
 As a member of the product development team, review new designs and existing products to ensure all requirements for the agency compliance and regulatory considerations are met.
 Prepare samples and certification packages for agency testing. Make applications to agencies, solve problems, and follow-up.
 Specify required labeling, statements, and warnings and review product labels, user manuals, and packaging artwork.
 Lead and direct all in-house or outside testing for medical device agency compliance of the product(s) against applicable regulatory standards.
 Lead in the creation, development and maintenance of in-house test procedures, test plans and guidelines to ensure product compliance to the latest regulatory standards.
 Lead and coordinate the Test lab equipment calibration, maintenance and documentation.
 Continue to monitor the latest electronic & medical device standards and inform management regarding the actions needed for product compliance. Manage the updates to the internal test procedures as necessary.
 Participate in Asia-Pacific standards bodies and trade association groups
 Initiate and or coordinate root cause analysis on non-compliances relating to regulatory issues.
 Lead, coordinate and perform all activities relating to agency approvals and or compliance. This includes requesting quotations and purchase requests as well as preparation of schedules, reports, risk assessments, test procedures, and test plans.
 Establish relationships with agencies for product safety, regulatory compliance, and other testing requirements and global certifications/marks (such as UL, CE, BEAB, GS and S marks). This would also include developing a network of vendors and or suppliers who could support these activities.

 

EDUCATIONAL QUALIFICATIONS:
 Required: Bachelor's Degree - MAJOR: Engineering, Electrical, Mechanical, Systems
 


EXPERIENCE:
 5 Years of Consumer Goods Industry Experience Required
 5 Years of Functional Experience Required
 Position Specific Requirement, if any: Minimum 5-10 Years of engineering/product development of electromechanical consumer products and/or medical devices Experience Required


PROFESSIONAL QUALIFICATIONS:
 Working knowledge of software/firmware development
 Experience with the safety and quality of battery cells and packs
 Required:
 Engineering experience must include; reliability, safety, regulatory and risk assessments for class I and II medical devices.
 Thorough knowledge of engineering principles, theories, concepts, techniques, industry practices, regulations (including familiarity with GMP and design control processes as defined by ISO and FDA guidelines), and policies associated with mechanical, electrical, or other engineering disciplines.
 Working knowledge of the agency standard requirements for household electrical and medical devices like UL1310, UL1431, IEC60335, EMC (emissions) requirements, EMI (Immunity), Bluetooth and other regulatory standards.
 Experience with Injection molding and rapid prototyping methods used for consumer electronics and devices.
 General knowledge of analog and power electronics theory and practical designs
 Hands-on experience in using DMM, AC source, power meter, soldering iron, oscilloscope as well as understanding electrical wiring diagram and/ or simple circuits
 Working knowledge of electronic product substance safety and environment requirements

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Are you interested in working for Colgate-Palmolive? You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by e-mail are not considered in the selection process. Become part of our team. We look forward to your application.

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognised brand names as Colgate, Palmolive, elmex, Tom’s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet.  

For more information about Colgate’s global business, visit the Company’s web site at http://www.colgatepalmolive.com. To learn more about Colgate Bright Smiles, Bright Futures® oral health education programme, please visit http://www.colgatebsbf.com. To learn more about Hill's and the Hill’s Food, Shelter & Love programme please visit http://www.hillspet.com. To learn more about Tom’s of Maine  please visit  http://www.tomsofmaine.com.

Reasonable accommodation during the application process is available for persons with disabilities. Please contact Application_Accommodation@colpal.com with the subject "Accommodation Request" should you require accommodation.


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