Director Of Product, Medical Devices Linusbio

Company Description Help us build a company with a unique science platform that enables new diagnostics and earlier interventions to support a better quality of life for people everywhere!

LinusBio is a patient-centric, precision medicine company headquartered in North Brunswick, NJ.
Originating from the world's leading exposome laboratory at Mount Sinai Health System, LinusBio identifies novel non-genomic biomarkers of health and disease for drug development and clinical use.

Using a strand of hair, our temporal exposomic sequencing platform maps the dynamic biochemical patterns of an individual's unique biological response to environmental exposures.
We focus on medical conditions that historically have had no objective measures to predict, diagnose, or characterize them, including CNS conditions (autism spectrum disorder, amyotrophic lateral sclerosis, schizophrenia) and gastrointestinal disorders (inflammatory bowel disease, eosinophilic esophagitis).

This year, we are commercializing our laboratory diagnostic for autism spectrum disorder after receiving an FDA Breakthrough Device designation.
Our Engineering infrastructure will be critical to this effort as well as the larger growth and success of our business.

Job Description The Director of Product, Medical Devices will lead the product design and development process and coordinate activities related to concept formulation and feasibility, design verification and validation, final validation and product launch preparation, and product launch and post-launch product assessment.
The Director of Product, Medical Devices is responsible for prioritizing product features and ensuring successful product releases.

The Director of Product, Medical Devices contributes to the development of new medical devices (laboratory developed tests) by playing a pivotal role in:

Ensuring the product is designed to deliver on its value proposition for addressing a customer segment's unmet need. Leading the project core team meetings from concept to commercialization by collaborating with staff from laboratory, data science, regulatory, quality, engineering, marketing, market access, and clinical teams. Ensuring end-to-end product documentation is compiled to meet all internal and compliance needs. Responsibilities Review and interpret outputs from the initial opportunity and risk analysis for the new product, including the financial review, market analysis and competitive assessment, early risk assessment, legal/IP analysis, and regulatory & clinical path. Coordinate activities related to product concept formulation and feasibility by establishing the project core team and initiating the project plan and timeline.
Coordinate with project team members to obtain detailed customer insights / voice of the customer (marketing), select the early product concept (lab and data science), define user needs and product requirements (including product software requirements such as Data Science Applications), manage the development of product features through the design control process, initiate the design history file and risk management plan (regulatory), monitor patent and trademark filings (legal), document regulatory strategy, determine product software requirements (engineering), identify initial reimbursement strategy (market access), and establish clinical validation plan (lab, data science, and regulatory).
Develop and manage the Product Roadmap including and not limited to: Overview of the product's purpose and significance for addressing a specific clinical need.

Market assessment – expansion from the initial market analysis.

Product design Intended user Product description and intended use User needs, design inputs and performance requirements Target product profile and minimal viable product profile Proof-of-concept testing Packaging requirements Regulatory strategy Design verification Analytical validation plan Clinical validation plan Development milestones, deliverables, and timelines.

Risk management and mitigation plan.

Ensure excellent cross-functional communication and decision-making related to design and development, verification and validation by facilitating project core team meetings and maintaining the product roadmap, project plan and timeline.
Coordinate with project core team members to ensure all inputs and activities are completed with attention to quality, including customer feedback on the product profile (marketing), product design verification and analytical validation design, history file, regulatory submissions, performance qualification, clinical validation plan (regulatory, lab, data science), and providing input towards non-product software (engineering), as needed. Coordinate the core team's efforts related to final validation and product launch preparation.
Update the Product Roadmap documentation with the completed DHF, risk management plan, design outputs and inputs, final patent review, regulatory clearance, operations scale up plan, full process qualification and final process performance qualification.
Incorporate test ordering operations into the Product Roadmap, and EMR integration.
Append the marketing plan, pricing recommendation, and reimbursement strategy from marketing and market access to the Product Roadmap.
Collaborate with marketing in creating the Product Offering document, so that it is consistent with the Product Roadmap.
Ensure all aspects of the Product Roadmap have been addressed and finalize documentation. Participate in Product Launch and Post Launch Assessment.
Ensure HCP training is documented.
Monitor product complaints and customer feedback provided by customer support staff and product uptake information from commercial analytics staff.
Monitor progress with pilots through information provided by health care alliances and market access staff.
Monitor quality audits.
Re-engage the project core team, as needed, for process improvements and design updates.
Update Product Roadmap and other documentation as needed. Requirements Bachelor's degree in a related field.
Graduate degree preferred. Minimum of 6-10 years of experience in product management in medical device or laboratory developed tests.
Must have experience with documentation with FDA-cleared IVD medical devices. Experience in Pediatric devices/ Telehealth a plus. Experience integrating with Enterprise and/or Hospital systems is a plus. Desirable Skills Operational mindset capable of managing plans with numerous cross-functional interdependencies. Skilled listener for interacting with subject matter experts across the organization. Problem-solver with strong consensus-building skills. Comfortable driving multiple projects forward simultaneously. Proficiency in FDA regulations for IVD, as well as requirements for CLIA and CAP accreditation. Excellent communication and presentation skills, with the ability to distill complex information into clear and actionable insights. Meticulous attention to detail in creating product documentation. Ability to work effectively in a fast-paced, dynamic environment with tight deadlines and evolving priorities. Planner and forward-thinker with a passion for innovation and a commitment to participating in high-functioning teams to deliver quality products that address customers' needs. Experience reading and understanding academic literature and whitepapers preferred. Background in biochemistry and/or products created through the use of mass spectrometry preferred.
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