Sr. Manager, IVD Systems Integration

About Akoya Biosciences, Inc.

As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion, and PhenoImager HT Instruments.

Job Description Summary

The Sr. Manager, IVD Systems Integration, is responsible for leading, managing, executing, and completing systems integration activities associated with the development of new technologies, new products, or improving existing products. This position exercises judgment and makes informed decisions using industry best practices and global standards to determine appropriate action or in selecting methods, techniques, and evaluation criteria. The ideal candidate will be a hands-on, subject- matter expert that promotes teamwork in a collaborative environment for the successful development of In Vitro Diagnostics (IVD) products.

Duties and Responsibilities

· Lead Systems Integration activities under the Akoya Biosciences Quality Management System including compliance with applicable national/international regulations, guidelines, and industry standards

· Lead the Akoya Systems Integration function and department to foster excellence in team performance, growth, and influence

· Accountable for “building the product right” or assessing and confirming product performance against design inputs

· Accountable for planning and execution of verification and validation activities at the system level

· Apply technical expertise to lead efforts in system design, implementation, integration, verification and validation (V&V) of medical devices and IVD products

· Assess design feasibility and verify product functionality and/or confirm product capabilities

· Participate in requirements management activities involving creation, decomposition, review, and traceability of requirements to product design outputs

· Prepare and deliver presentations of V&V activity results to others; presents data to larger and more diverse audiences

· Responsible for documenting system interfaces, interoperability requirements and test method development

· Participate in new product design and design improvements to existing products

· Engage with the Original Equipment Manufacturer (OEM) to provide technical oversight and guidance on design verification and validation

· Communicate and collaborate closely with functional area leads and Core Team members to drive system integration and optimization

· Ensure the necessary documentation for V&V activities are included in the project Design History File (DHF)

· Assist in the development of manufacturing processes and troubleshooting issues to determine root cause and possible engineering solutions

· Participate in Human Factors Engineering/Usability Engineering tasks and activities

· Participate in product risk management activities involving system Hazard Analysis (HA) and Failure Modes and Effects Analysis (FMEA)

· Utilize integration, analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system issues

· Apply working knowledge of design of experiments (DOE), analysis and interpretation of test results, failure investigation and root cause failure analysis

· Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

· Other duties as assigned

Qualifications/Skills

· BS degree in Science or Engineering with a minimum of 10 years of experience in medical device or IVD industries or MS/Ph.D. degree in Science or Engineering with a minimum of 3 years in medical device or IVD industries

· Proven track record as a leader developing diagnostic tests, reagent kits or diagnostic systems

· Understanding of ISO 13485 standard and Code of Federal Regulations (CFR) 21§ 820.30 Design Controls and previous experience developing products under design control as well as risk management standards (e.g., ISO 14971)

· Experience in complying with IVDD (98/79/EC) and IVDR

· Detailed knowledge of requirements management and risk-based testing approaches

· Experience assembling documentation to support ISO, CE mark, 510(k) and/or PMA submissions

· Scientific and business acumen leading to data-driven decisions

· Able to prioritize and manage multiple concurrent projects and drive to results with a high emphasis on quality

· Demonstrated ability to be highly effective in a fast-paced, rapid growth environment and a strong team player

· Experience with immunohistochemistry/immunofluorescence, preferred

· Design for Six Sigma (DFSS) experience

· Proficiency with common requirements management tools, preferred

The hiring range for this position is $165,000 - $190,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Akoya’s excellent benefits program includes a selection of Medical and Dental plans, and Life, AD&D and Short-Term Disability insurance, Tuition Reimbursement, 401(k) with immediate Company match vesting, Company paid holidays and more!

Akoya values bringing together individuals with diverse backgrounds. We are proud to be an Equal Opportunity/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.