Opportunities

Challenges motivate us and collaboration facilitates our success. We are energized by the fast-paced environment of medtech innovation. We commit to delivering client
results and fostering professional development.

History

Mike and Darlene established Experien Group to address resource challenges they faced as senior executives in the medical device industry. They recognized that companies large and small need a cohesive team of experts to hit meaningful milestones. With measured growth, they have personally selected and developed a group of professionals who share their mission and demonstrate significant value for our clients.

Culture

Our work is serious but our team brings passion and fun to the process. Mike and Darlene have maintained a family dynamic since the firm’s beginning and our staff genuinely value one another. Experien = Excellence, Experience, Expertise and Entrepreneurship. Group = Community, Collaboration, Contribution and Engagement.

Future

Business models and regulatory challenges modulate over time. We evolve with the industry, supporting traditional device companies as well as newer entrants to the marketplace. We maintain a full-service firm with the breadth and depth to help companies commercialize wide-ranging, clinically impactful technologies.

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Mentorship

Our team is continually learning; we evolve together. With a hands-on culture combining junior and senior resources, we deliver efficient and superior results for our clients and professional development opportunities for our staff. We are current to the latest industry requirements and strive always to be best-in-class.

Openings

Our firm’s strength comes from its people. We seek motivated, engaging professionals who enjoy a fast-paced, collaborative environment. We roll up our sleeves to work alongside our clients and look for applicants who thrive under this approach. We welcome serious inquiries about joining Experien Group.

Current openings
Vice President of Clinical Affairs

We are seeking a hands-on, seasoned, Vice President of Clinical Affairs to lead U.S. and international regulatory activities for Experien Group clients.

Vice President of Clinical Affairs

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.

Experien Group is seeking a hands-on, seasoned, Vice President of Clinical Affairs to lead U.S. and international regulatory activities for Experien Group clients. The ideal candidate has at least 10+ years of experience directing complex medical device clinical studies, preferably for Class III devices. In addition to having a proven track record of successful clinical study experience, this candidate must have strong people management skills, great attention to detail, solid organizational prowess and the ability to anticipate challenges and think strategically. This position may require up to 50% travel, both domestic and international.

MAJOR DUTIES OF POSITION:

  • Lead multiple aspects of Class II and III clinical studies from enrollment planning to close-out, to assure adherence to intended timelines and achievement of study goals/budgets.
  • Lead a team to successfully drive clinical studies in accordance with appropriate quality standards.
  • Collaborate with Regulatory, Quality, and other functions to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, clinical evaluations and other deliverables related to the product lifecycle management. This includes risk management support, new product development processes and design history file development.
  • Develop and maintain product line technical expertise and contacts with Key Opinion Leaders and customers of product responsibility by observing surgery, attending medical/scientific meetings, presentations and seminars while gathering competitive information.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Minimum of 10+ years clinical experience delivering complex clinical programs on time, within budget, and in compliance with FDA/IRB and EC requirements.
  • Comprehensive understanding of applicable clinical research regulations in multiple geographies.
  • Knowledge and experience with global medical device regulations - ICH/GCP (International Conference of Harmonization/ Good Clinical Practice).
  • Experience interacting with top-level executives and Key Opinion Leaders.
  • Extensive experience in managing and interpreting complex clinical trials.
  • Knowledge of clinical research process and methodology, market research strategies, real-world evidence and technologies.
  • Prior experience with FDA relating to the design and conduct of clinical trials and maintains Bioresearch Monitoring (BIMO) compliance.
  • Minimum of a Bachelor’s Degree with demonstrated academic success plus experience with development and management of clinical affairs.
  • High level of professionalism, strong leadership attributes and commitment to mentoring.
  • Experienced presenter, superior technical writer and excellent verbal and written communication skills.
  • Ability to lead cross-functional programs, devise roadmap for success and drive projects to timely completion within budget.
  • Strong relationships in the medical device community and ability to represent firm at industry meetings, professional conferences, Scientific Advisory Boards, etc.

HIGHLY DESIRABLE EXPERIENCE:

  • Experience in Class III (PMA) medical devices
  • Bi-lingual (proficient in Spanish)
  • Clinical research certification (SoCRA or ACRP)

BENEFITS:

  • Industry Competitive Salary
  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)
Please send your resume.
Clinical Research Associate – San Jose

We are seeking an experienced Clinical Research Associate to support our clinical operations team.

Clinical Research Associate – San Jose

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.

We are seeking an experienced Clinical Research Associate to support our clinical operations team. The Clinical Research Associate (CRA) will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. CRAs support study activities to meet protocol and client objectives, maintaining regulatory compliance and professional integrity for the clinical trials.

MAJOR DUTIES OF POSITION:

  • Responsible for ensuring that the site coordinators and investigators comply with the study protocol, Good Clinical Practices (GCP), Code of Federal Regulations (CFR) and Institutional Review Board (IRB)/Ethics Committee (EC) requirements.
  • Act as primary liaison to the site. Activities may include site qualification visits, site initiation visits and training, monitoring visits to review the study data and verify the accuracy of the data against the site’s medical records, and site close-out visit.
  • Contribute to protocol and CRF development as well as the clinical study report at the end of the study to report the study results to the FDA and other regulatory authorities.
  • Ensuring data quality by maintaining compliance, reviewing adverse events and device complaints, reviewing audit reports, and implementing corrective actions (when needed).
  • Support maintenance of department SOPs and work instructions.
  • Supports investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned goods.
  • Supports and maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • A minimum of 3-5 years of directly related work experience or equivalent in clinical research, including work on medical device class I- III IDE trials, is required
  • Typically an RN, have a BSN or have a BS or BA in a relevant scientific discipline
  • Knowledge of GCPs, CFRs and IRB procedures is required
  • Accuracy, reliability, and high level of attention to detail are necessities
  • Strong level of professionalism, including verbal and written skills, is critical
  • Proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint is mandatory

BENEFITS

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)
Please send your resume.
Senior Quality Engineer – San Jose

We are seeking a Senior Quality Engineer who will be responsible for managing design control and risk management activities during device life cycle.

Senior Quality Engineer – San Jose

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.

We are seeking a Senior Quality Engineer who will be responsible for managing design control and risk management activities during device life cycle. We work across a broad spectrum of technologies and treatment modalities and are looking for an individual to organize and manage the Quality activities for clients to help them identify and meet their Quality Management System needs. Additionally, the Senior Quality Engineer will evaluate design outputs for quality requirements and establish quality, risk, or other management plans for equipment and processes for general and specific product performance needs. These activities must be in accordance with industry standards testing, FDA Quality System Regulation, ISO 13485, ISO 14971, and the Medical Device Directive.

MAJOR DUTIES OF POSITION:

  • Perform device design control and quality engineering activities. This will include working with outside clients to complete design control activities.
  • Support cross-functional teams in developing and executing Verification and Validation Plans, including writing and executing related protocols and reports.
  • Provide Risk Management expertise in the evaluation and design of product, design validation and verification, complaint and nonconforming materials investigations and implementation of corrective and preventive action (CAPA), as required.
  • Hold responsibility for applying appropriate design controls, manufacturing controls, quality assurance techniques and controls, and statistical controls and methodology throughout the life cycle for respective products.
  • Maintain accountability for project timelines and deliverables to both internal and external management.
  • Facilitate the documentation of risk management using industry standard tools including FMEAs and Fault Tree Analysis for systems, subsystems, manufacturing processes and clinical workflows to ISO 14971.
  • Drive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.
  • Ensure completion and documentation of verification and validation activities, including traceability to requirements in compliance with applicable quality system regulations.
  • Provide input and/or oversight for other quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Bachelor degree in Engineering or Life Sciences required, master’s degree preferred.
  • 4-8 years of medical device industry experience required, may consider applicants with more senior level experience.
  • High attention to detail and project management skills a must.
  • Knowledge of medical device regulations and standards (i.e., QSR, ISO 13485, ISO 14971, ISO 60601 series, ISO 62304, ISO 10993 series, ISO 11135, and ISO 11137) required.
  • Experience in a full product life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service and post market analysis is critical.
  • Sound understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product servicing is necessary.
  • Excellent verbal and writing skills are required.

BENEFITS:

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)
Please send your resume.
Senior Quality Engineer – San Diego

We are seeking a Senior Quality Engineer who will be responsible for managing design control and risk management activities during device life cycle.

Senior Quality Engineer – San Diego

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.

We are seeking a Senior Quality Engineer who will be responsible for managing design control and risk management activities during device life cycle. We work across a broad spectrum of technologies and treatment modalities and are looking for an individual to organize and manage the Quality activities for clients to help them identify and meet their Quality Management System needs. Additionally, the Senior Quality Engineer will evaluate design outputs for quality requirements and establish quality, risk, or other management plans for equipment and processes for general and specific product performance needs. These activities must be in accordance with industry standards testing, FDA Quality System Regulation, ISO 13485, ISO 14971, and the Medical Device Directive.

MAJOR DUTIES OF POSITION:

  • Perform device design control and quality engineering activities. This will include working with outside clients to complete design control activities.
  • Support cross-functional teams in developing and executing Verification and Validation Plans, including writing and executing related protocols and reports.
  • Provide Risk Management expertise in the evaluation and design of product, design validation and verification, complaint and nonconforming materials investigations and implementation of corrective and preventive action (CAPA), as required.
  • Hold responsibility for applying appropriate design controls, manufacturing controls, quality assurance techniques and controls, and statistical controls and methodology throughout the life cycle for respective products.
  • Maintain accountability for project timelines and deliverables to both internal and external management.
  • Facilitate the documentation of risk management using industry standard tools including FMEAs and Fault Tree Analysis for systems, subsystems, manufacturing processes and clinical workflows to ISO 14971.
  • Drive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.
  • Ensure completion and documentation of verification and validation activities, including traceability to requirements in compliance with applicable quality system regulations.
  • Provide input and/or oversight for other quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Bachelor degree in Engineering or Life Sciences required, master’s degree preferred.
  • 4-8 years of medical device industry experience required, may consider applicants with more senior level experience.
  • High attention to detail and project management skills a must.
  • Knowledge of medical device regulations and standards (i.e., QSR, ISO 13485, ISO 14971, ISO 60601 series, ISO 62304, ISO 10993 series, ISO 11135, and ISO 11137) required.
  • Experience in a full product life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service and post market analysis is critical.
  • Sound understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product servicing is necessary.
  • Excellent verbal and writing skills are required.

BENEFITS:

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)
Please send your resume.
General Application

If you do not currently see a vacancy that fits your area of expertise, please feel free to submit a resume for us to keep on file for future listings.

General Application

If you do not currently see a vacancy that fits your area of expertise, please feel free to submit a resume for us to keep on file for future listings.

Please send your resume.