1 | Sr. Upstream Product Manager

Position Summary:

The Sr. Product Manager is tasked with identifying market trends, opportunities and competitive environment to form strategic plans for product development and commercial success. Leads the effort to initiate new product strategies in the form of supporting existing brands and/or sub-segments and creating new products. Works across multiple internal and external groups such as design, packaging and labeling, regulatory claims, surgical technique generation, advertising, sales force education, etc. to enable professional product launches across US and global markets.

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Key Responsibilities:

• Conduct market research to identify customer needs, market trends, and competitive landscape in the targeted disease therapies and competitive products/procedures. Gather customer feedback, analyze market data, and stay updated with industry developments.

• Develop product strategies and roadmaps based on market insights and business goals. Collaborate with cross-functional teams in R&D, Operations, Education and others to define product features, prioritize enhancements, and align product roadmap with business objectives.

• Lead and collaborate on product development activities to ensure coordinated and timely launch of technologies. Take strong role in transitioning new product development from R&D to pre-launch development engineering, coordinating key GTM activities to enable fully transparent and well-planned product launch alongside downstream marketing and sales team.

• Oversee the product development lifecycle, including requirement gathering, design, testing, and launch activities such as messaging, internal and external education, product branding and launch timing per geography. Coordinating with engineering, design, and quality assurance teams to ensure timely and successful delivery of high-quality platform technologies and accessories.

• Monitor product performance, analyzing sales data, and identifying areas for improvement.

• Develop business justification for recommendations and gain alignment across key stakeholders on project/feature prioritization for core and expansion opportunities.

• Support/manage industry partnerships and collaborations for pre-market/development stage projects.

• Partner with global counterparts/partners to develop and implement specific product launch and product cycle activities OUS.

Qualifications and Skills:

• Bachelor’s degree required, (graduate degree in science, engineering, marketing or related field preferred)

• 6-8 years of marketing experience required or overall related experience or commensurate experience required in medical devices product management, preferably launching complex medical devices into competitive markets.

• In-depth knowledge of the medical devices industry, including regulatory requirements and compliance standards, to ensure the successful development and launch of innovative products.

• Strong project management skills to effectively plan and oversee the entire product lifecycle, from ideation to commercialization, while meeting deadlines and staying within budget.

• Excellent market research and analysis capabilities to identify customer needs, market trends, and competitive landscape, informing product strategy and decision-making.

• Effective communication and collaboration skills to work cross-functionally with engineering, marketing, sales, and regulatory teams, fostering strong relationships and driving successful product development and commercialization.

• Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills. Highly motivated, efficient, and enterprising with an inherent ability to drive tasks and projects to full completion.

• Strong analytical, critical thinking, and problem-solving skills with attention to detail and organizational goals.

• Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 25% of the time.

• Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager

• Proficient in Microsoft Office, Word, and Power Point and clinical database management software

2 | Director of Clinical Operations

Position Summary:

The Director of Clinical Operations will oversee and lead the Clinical Operations team ensuring the successful planning, execution, and management of clinical trials and studies. This individual will be responsible for the execution and reporting of clinical programs, from early-stage development through commercialization, in compliance with regulatory requirements and industry best practices. The role requires a deep understanding of clinical trial management, medical device regulations, and cross-functional collaboration with internal teams, including R&D, regulatory affairs, quality assurance, and marketing.

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Essential Duties:

Clinical Trial Leadership and Oversight:

• Lead the implementation and management of clinical trials for new indications and for clinical studies for existing indications.

• Ensure that clinical trials and studies are conducted in compliance with GCP (Good Clinical Practice), FDA regulations, and international regulatory standards.

• Direct and oversee the execution of clinical trials and studies, ensuring timely and on-budget delivery of key milestones.

• Establish, monitor, and optimize processes for clinical operations to ensure efficiency and adherence to timelines and budgets.

Cross-functional Collaboration:

• Work closely with R&D, regulatory affairs, quality assurance, and other key departments to ensure alignment and effective communication throughout clinical trials.

• Collaborate with the regulatory affairs team to ensure clinical trial data supports regulatory submissions and approval processes (e.g., FDA 510(k), PMA, CE Mark).

Clinical Study Planning:

• In tandem with the Data Science Team, develop and review clinical study protocols, case report forms, and informed consent documents.

• Oversee the planning and execution of clinical site selection, patient recruitment, and enrollment strategies.

• Ensure clinical trials are conducted with high integrity, data quality, and patient safety

 Regulatory and Compliance Management:

• Stay current on FDA, EMA, and other global regulatory guidelines and best practices for clinical trials involving medical devices.

• Ensure all clinical trials are fully compliant with regulatory requirements and that any deviations or issues are promptly addressed.

• Manage the preparation of clinical trial documentation and regulatory submissions to support product approvals and claims.

Risk Management and Problem Solving:

• Identify potential risks and challenges within clinical operations and proactively implement mitigation strategies.

• Resolve clinical trial issues as they arise, ensuring minimal impact on timelines and regulatory compliance.

Team Management and Development:

• Lead, mentor, and manage a team of clinical operations professionals, including Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and other clinical personnel.

• Conduct performance evaluations, identify training needs, and foster professional development within the clinical operations team.

• Provide leadership in the hiring, onboarding, and resource planning for the clinical operations function.

Budgeting and Resource Management:

• Develop and manage the clinical trial budget, ensuring proper allocation of resources.

• Oversee vendor management and selection of Contract Research Organizations (CROs) or other third-party clinical service providers.

• Ensure cost-effective management of clinical trials while maintaining quality and compliance.

Desired Qualifications:

• Bachelor's degree in Life Sciences, Nursing, or related field. A master’s degree or MBA is preferred.

• At least 10 years of clinical operations experience in the medical device industry, with a focus on managing clinical trials.

• Minimum of 4 years in a leadership role, with proven experience in managing clinical operations teams and cross-functional collaboration.

• Expertise in regulatory requirements and clinical trial management for medical devices.

• Experience with both early phase (e.g., feasibility) and late-phase clinical trials, as well as post-market clinical studies.

• Strong knowledge of clinical research methodologies and trial management processes.

• Excellent leadership, team-building, and interpersonal skills.

• In-depth understanding of FDA and other global clinical trial regulations and standards.

• Strong project management, organizational, and budget management skills.

• Excellent communication and presentation skills, with the ability to interact with senior leadership, regulatory bodies, and clinical investigators. 

3 | Upstream Pr. Clinical Program Manager

Position Summary:

The Upstream Pr. Clinical Program Manager will integrate with R&D during product development for new device indications and will partner with Regulatory, Marketing, and R&D to design pre-market feasibility and pivotal clinical studies to satisfy regulatory requirements and support marketing claims.  This position will play a critical role in generating evidence for future applications.  The Upstream Pr. Clinical Program Manager will report to the Director of Data Science. 

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Key Resposibilities:

• Works with key stakeholders to design clinical studies that meet key business objectives which may include the following:

  • Collect clinical safety and performance data to meet regulatory requirements in key regions

  • Collect clinical data to meet post-market requirements (e.g., CPT code applications, marketing claims, etc.)

• Works with key stakeholders to ensure appropriate data elements are captured during CRF development

• Partners with R&D, Professional Education and Medical Affairs to aid in procedure development for new indications

• Supports the planning and coordination of clinical advisory boards to guide research activities as needed

• Assists the Regulatory Affairs and Quality Assurance teams in preparation for reporting and submissions

• May assist in internal and external audits

• Develops and maintains strong relationships with physician collaborators

Qualifications and Skills:

The requirements listed below are representative of the knowledge, skill, and/or ability necessary for satisfactory performance. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Master’s degree in technical or scientific field

• Minimum of 10 years’ medical device clinical study experience

• Knowledge of, and experience with, the FDA and the EU regulatory environments

4 | Business Development Leader  (FILLED)

ARIS Executive Search has been retained to recruit a Business Development Leader for a client that is notable in medical device contract manufacturing, specializing in tight tolerance, precision medical components using the latest extrusion and molding processes. This Company utilizes a comprehensive quality control system in their two state-of-the-art facilities, to achieve the highest quality standards in the industry.

​This successful Company specializes in etched PTFE (polytetrafluoroethylene) which is a synthetic fluoropolymer used as a liner in catheters due to its unique properties. PTGE has a very low coefficient of friction, helping to reduce friction in delivery systems and making it easier to advance devices such as stents or balloons. 

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Additionally, this company manufactures FEP heat shrink tubing, guide catheters and tri-layer tubing and offer custom extrusion, secondary processing and engineering services to assist with new product development. Located in Asia, the company counts 205 employees among its growing workforces. 

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About the Role:

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​The Business Development Leader will be the first US hire. This person will be responsible for introducing the company to the US market and selling medical tubing and catheter manufacturing services to medical device OEM's. This first hire will have an amazing opportunity to build out business in the US and help grow the company. This role will initially report to the CEO and Founder but will transition to reporting to the VP of Sales based in the US. 

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The territory for this role will primarily be Minneapolis, MN and the West Coast. The Company currently has a number of US based accounts so there is an existing account base. 

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The Asia office consists of R&D, quality, marketing and other operational roles. The Asian team is fluent in English. The time difference can be challenging so this person should be comfortable doing evening calls as needed.

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An ideal candidate has experience selling to medical device OEM's and will have solid relationships with Supply Chain Directors and R&D within those companies. Catheter experience is a "must have" preferable within cardiovascular, peripheral, or endoscopic. This person must be a go-getter and know how to knock on and open doors and work independently with an entrepreneurial spirit.

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The Company is well funded and has grown rapidly. They have seen a 100% increase year over year with 45% growth last year. 

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All interviews will be virtual until the right candidate is identified. A nominating committee will approve the first US hire, as this is an important decision and role. A US consultant will interview final candidates in-person. Having hustle, a good network and experience with cardiovascular, peripheral or endoscopic catheters is key to this hire. 

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Compensation includes a generous base salary, plus commission and equity in the company. The company is in the process of setting up a US benefits package including health insurance and 401k with a company match.