Verification & Validation Manager

RXinsider LTD.; Goleta (CA); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking an experienced leader to direct verification and validation testing, ensuring software and product quality and regulatory compliance.

The role interfaces with software/systems engineering, quality, and regulatory teams to align test strategies with development lifecycle. Responsibilities include building the V&V group, defining goals, creating test artifacts, and introducing best practices in FDA/EU compliance, with a focus on automation and efficient test

Qualifications

• Minimum 8–10 years in medical device development with a bachelor’s degree or 5–7 years with a Master’s in science/engineering.
• Minimum of 2 years’ experience supervising technical staff.
• Desirable: experience in regulated environments; IEC-60601-1, IEC-14971, IEC-62304; OR support; image processing; test equipment; software test automation; Scrum/Agile.

Responsibilities

• Develop, lead, and manage the V&V engineering group.
• Define and track goal progress for team members.
• Support development and maintenance of Product and Software Requirements Specifications.
• Develop test cases, protocols, and plans; oversee execution and deliver final reports.
• Software verification testing against the software requirements specifications.
• Introduce V&V best practices in FDA/EU compliance.
• Develop test automation framework.
• Manage hardware and software resources for testing.
• Collaborate with project managers to ensure on-time completion.

Skills

V&V management

Regulatory knowledge

Problem solving

Communication

Adaptability

Product lifecycle

Education

Bachelor's in science/engineering

Master's in science/engineering

Tools

Microsoft Word

Excel

Outlook

Job description

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.

To learn more about B. Braun Medical, visit www.bbraunusa.com.

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Summary

This position will direct and oversee the teams, processes, and tools responsible for product verification and software validation testing, including software quality assurance. It is responsible for the creation and maintenance of test cases and protocols to ensure that product and software quality standards are achieved, and that all regulatory expectations are met. It will also oversee the execution and reporting of Verification test efforts, including document approval and release. This role will interface closely with software engineering, systems engineering, biomedical/clinical engineering, product management, project management, quality, and regulatory.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following. Other duties may be assigned.

• Develop, lead, and manage the V&V engineering group.
• Define and track goal progress for individual team members
• Support the development and maintenance of Product and Software Requirements Specifications
• Develop test cases, protocols, and plans; Perform and oversee execution of these test cases, protocols, and plans; Deliver final test reports
  • Hardware and system testing against the product requirements, including testing against optical standards, visual perception and mechanical capability
  • Preparation for and Management of External Testing, including: Safety testing per IEC-60601-1, Wireless, Shipping, EMC Testing, etc.
  • Understand accelerated lifecycle testing to prove reliability
  • Software verification testing against the software requirements specifications.
• Introduce V&V best practices in compliance with FDA and EU medical device product development, and measure team performance against best practices
• Develop test automation framework to achieve (1) early defect detection and (2) reduced manual test effort.
• Manage hardware and software resources required to support testing
• Work with project managers to ensure that projects are completed on time, and within budget.
• Contribute as needed to help the V&V team to achieve project goals and milestones
• Act as the technical point-of-contact for customer reports issues and provide support to the Technical Support team as needed.

COMPETENCIES

To perform the job successfully, an individual should demonstrate the following competencies:

• Ability to manage V&V team members
• Understanding of medical device product regulations, FDA and EU
• Ability to maintain high team morale through excellent communication, management, and encouragement.
• Demonstrated ability to creatively and proactively solve problems.
• Flexible in working under changing and different work settings.
• Demonstrate knowledge of the company product development lifecycle and the process tools.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

Mandatory

• Requires a minimum 8-10 years’ experience in medical device development with a bachelor’s degree or 5-7 years’ experience in medical device development with a Master’s Degree in science/engineering from an accredited university, or equivalent work experience in medical device development.
• Minimum of 2 years’ experience supervising technical staff.

Desirable

• Experience developing medical devices, or working in a regulated environment
• Understanding of IEC-60601-1, IEC-14971, and IEC-62304 for medical device development
• Experience being in the operating room (OR) supporting live surgeries as a design engineer, tech. support, service engineer, or sales representative. Knowing OR sterility protocols, medical equipment
• Understanding basic image processing concepts and techniques
• Hands-on background in operation and use of standard test equipment; oscilloscopes, digital multimeters, frequency generators, calipers etc. Ability to troubleshoot and analyze electronics.
• Background in software test automation
• Knowledge of different medical imaging modes such as optical microscopy, intraoperative fluorescence, X-rays, CT scans, MRI, OCT, etc.
• Experience working with Scrum/Agile

Language

Demonstrate excellent communication and documentation skills, both written and oral. Ability to read, analyze, and interpret technical procedures or governmental regulations. Ability to write reports and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math

Demonstrate ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Apply concepts of basic algebra and geometry.

Reasoning

Demonstrate ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

To perform this job successfully, an individual should have strong computer skills, knowledge of Microsoft Word, Excel and Outlook. The individual should also be able to troubleshoot PC-based systems, hardware, and software.

Physical Requirements

The physical demands 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. While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must frequently lift and/or move up to 30 pounds and occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

• healthcare
• a 401(k) plan
• tuition reimbursement

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.