Technical Lead

he Technical Lead is responsible for supporting the US Operations with technical / project support and reducing project risk with ongoing technical training.

The Duties of the Technical Lead include but are not limited to:

• Perform audits and/or project assessment as authorized
• Represent a senior technical reference in a field (products, technology, processes)
• Support auditors, product assessors, expertise managers, and relationship managers by sharing knowledge, alongside other Technical Leads

The responsibilities of the Technical Manager include but are not limited to:

• Maintain and continuously develop his/her knowledge on the designated domain of expertise

 As part of the Technical Lead team:

• Provide regulatory, technical and process direction to experts as needed and be a point of contact/escalation for technical questions
• Liaise with global PO’s, SPS’s, CAPS, Certification Bodies, and other regional operations to ensure appropriate technical and process solutions are found and communicated
• Support MHS America employees with training on all conformity assessment schemes o Provide solutions for complex issues and distill complex topics into clear communications
• Support case by case development of integrated conformity assessment scheme project plans, aligning project tactics with project strategy
• Support development strategies for accomplishing specific project objectives o Support solutions when projects are at risk.

Knowledge and Skills:

• Strong knowledge in medical devices regulatory requirements, as well as quality management system and risk management system requirements
• Strong working knowledge of regulatory framework of MDD, MDR, IVDR, MDSAP, EN ISO/ISO 13485 and ISO 9001
• Strong working knowledge of quality and conformity assessment standards like EN ISO/ISO 13485 and ISO 9001, ISO 17021, ISO/IEC 17065, ISO 17025
• Sound knowledge of medical devices/IVDs and the related manufacturing activities, including;  their intended use, types of medical devices including their complexities, technologies, and risk classifications, safety and risks of medical devices, processes and technologies used by medical device manufacturers
• Strong knowledge of standards and techniques for auditing quality management systems
• Ability to interpret regulations from a technical, as well as legal perspective
• Ability to quickly assimilate and assess new information and develop plans to react to it
• Strong analytical, problem solving, pragmatic approach, and process improvement skills
• Ability to prioritize and perform required follow up
• Ability to work well in a team of similar technical experts to find solutions
• Good networking skills, able to work in cross functional teams
• Strong work ethic
• Excellent verbal and written communication and presentation skills
• Able to work well under pressure to handle crisis situations and balance several tasks simultaneously
• Proficiency in Microsoft applications
• Must be confident, highly efficient, and self-motivated Must be personable and work well independently, as well as in a team and matrix environment.

Minimum Qualifications

• Bachelor’s degree in technical related field (Engineering, Biomedical Sciences, etc.)

• Maintenance of all authorizations.

Preferred Qualifications:

• Master’s degree in a technical/scientific field – preferably medical devices / IVDs

Required Experience

• 4 years of experience in regulatory affairs, product development, research & development, clinical research; a relevant Master/PhD degree substitutes up to three year of four years’ work

experience.

• Experience with CE marking, Medical Device Directive, Medical Device Regulation, ISO 13485, and MDSAP certification

• 2 years Quality Assurance experience

• As an equivalent to a degree eight years’ experience in the technological area OR five years’ experience in the technological area combined with independently examined technical training

substitute a lower level of tertiary qualification

• Demonstrated ability or previous experience as a team leader or supervisor, preferred.

• Auditing/product assessment practice

• appropriate knowledge and experience of risk management and related medical device standards and guidance documents

Physical Demands

• Applicable Frequency
• Standing 
• Walking 
• Sitting (home) office work for most of the time
• Stooping/Bending/Reaching 
• Pushing/Pulling 
•  Lifting and carrying approx. 1 – 10 lbs. X Weight Daily

Equal Opportunity Employer – Disability and Veteran

TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following: Labor Law Posters