DESIGN VERIFICATION MANAGER II
- The V&V Engineering Manager is responsible for the engineering efforts for design verification activities for new products and changes to existing products. This position manages the system design verification engineers, software verification engineers, and software test technicians to support project teams performing design verification testing and FDA equivalency testing.
- The position will primarily oversee on Software V&V responsibilities and execution.
- Shares responsibility for overall success of KCI product design control activities.
Principle Responsibilities: (essential job duties and responsibilities)
Manage Software Design Verification Engineering:
- Supervises and coordinates the Software V&V activities and resources for the following activities:
- Verification of test methods and equipment, performing tests, writing test reports, supporting Medical Regulatory Submissions, training for products, training others in processes, assist in lab management and organization, manage test resource schedule, internal auditor, review documents for others, assist in hiring of contract employees ( assisted in interview process), manage time lines of project test schedules, ensures design of test fixtures and tests, and development of requirements.
- When needed, also supervise over related product/system V&V activities similarly as well.
Design Verification Leadership/SME:
- Establishes design verification procedures to ensure medical device products are thoroughly tested and demonstrated to be safe, reliable and in compliance with internal, US and internal requirements and standards.
- Authors, reviews and/or approves process and product validation protocols, reports and equipment qualifications.
- Uses statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
- Effectively manages project schedules, workload and resources (internal and external).
Skills and Experiences:
- Experience in regulated laboratory environments, FDA or ISO registered work experience
- Strong technical problem solving skills.
- Good organizational and time management skills.
- An approachable manner and good communication skills.
- Good technical writing skills with the ability to produce clear work instructions.
- Ability to work effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.
- Leadership skills to motivate staff and manage a team to meet targets and deadlines
- Excellent problem-solving skills with effective decision making skills
- Flexibility with working hours.
- An awareness of health and safety issuesMoreInformationDesc
- BS technical degree with a minimum 5 years engineering experience; or BS in a non-technical degree with a minimum of 10 years engineering experience.
- Quality System experience within an FDA regulated industry
- Masters degree in Engineering or related degree, or in management
- Familiarity with data acquisition and control software, such as LabView and C++.
- Working knowledge of PEMAC, NuGenesis, and/or Agile.
- Broad base of experience in the development and testing of electronic, electro-mechanical, mechanical, chemical, and biological systems in the medical device industry.
- ISO 17025 and/ or CSA knowledge and experience
- ASCP, NELAC, or other laboratory board certification.
- OSHA training certifications
Education: Bachelors degree requiredThe information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description 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. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor