Biomaterials Engineer for Medical Devices & Documentation

TechDigital Group

Blue Ash (OH)

On-site

USD 85,000 - 125,000

Full time

14 days+

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Job summary

An established industry player is seeking a detail-oriented engineer to ensure the accuracy of engineering documentation related to medical devices. This role involves quality reviews, documentation drafting, and regulatory support, all crucial for product development. The ideal candidate will have strong knowledge in materials engineering and biocompatibility processes, contributing to innovative solutions in medical device design. Join a collaborative team focused on enhancing product quality and compliance, making a significant impact in the medical field. If you are passionate about engineering and regulatory processes, this opportunity is perfect for you.

Qualifications

  • Strong knowledge of biocompatibility processes and materials engineering.
  • Experience in medical device design and regulatory documentation.

Responsibilities

  • Review and maintain engineering documentation for accuracy and compliance.
  • Support product development and regulatory approval processes.

Skills

Materials engineering
Biomaterials
Medical device design
Regulatory documentation
Biocompatibility

Tools

iMOE database

Job description

About the role
As an Associate Director – Consulting (Life Sciences Commercial Sales, Service, Repair and Field Service SME), you will make an impact by serving as a subject matter expert and consulting leader for commercial transformation initiatives across MedTech and Medical Device clients. You will be a valued member of the Life Sciences Commercial team and work collaboratively with managers, primary teams, and other stakeholders and clients.

In this role, you will:

Lead MedTech and Medical Device commercial sales, service, repair, and field service consulting engagements—shaping target operating models, roadmaps, and execution plans and advising senior stakeholders.

Serve as a subject matter expert for device service and repair capabilities (e.g., installation, preventive maintenance, break/fix, depot repair, returns, warranty/entitlements) and their integration with commercial sales motions (e.g., service attach, renewals, upsell).

Design and improve end-to-end processes across lead-to-order, quote-to-cash, order-to-cash, service-to-resolution, and returns/RMA—driving cycle time reduction, quality, compliance, and customer experience.

Translate business requirements into functional solution designs for commercial sales and service/field service platforms (e.g., case management, FSM scheduling/dispatch, technician mobility, knowledge, parts/asset management), partnering closely with product, architecture, and delivery teams.

Own end-to-end consulting delivery for MedTech sales/service transformation programs—from problem definition and current-state assessment through implementation support, adoption, and value realization.

Partner with cross-functional stakeholders (Sales, Service Operations, Quality/Regulatory, Supply Chain/Parts, Finance, IT, and Customer Support) to align governance, KPIs, and operating rhythms.

Identify and shape opportunities across commercial sales effectiveness, field service modernization, and service revenue growth (e.g., contracts, renewals, entitlements, warranty optimization).

Develop accelerators, frameworks, and reusable assets for MedTech commercial sales/service and field service engagements; mentor consultants and managers on domain processes and consulting best practices.



Work model
We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a remote position open to qualified applicants in the United States. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs.

The working arrangements for this role are accurate as of the date of posting. This may change based on the project you're engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.

What you must have to be considered

Bachelor's or Master's degree in Engineering, Life Sciences, Business, Operations/Supply Chain, or a related field.

14–18 years of experience in MedTech/Medical Devices commercial consulting and/or industry roles focused on commercial sales operations, service/repair operations, customer support, and/or field service transformation.

Proven experience leading complex, multi-workstream transformation programs (process, data, technology, and change management) and building trusted relationships with senior client stakeholders.

Strong functional expertise in medical device service and field service operations, including scheduling/dispatch, technician mobility, parts logistics, asset/installed base management, service contracts/entitlements, warranty, and performance management (SLAs/KPIs).

Demonstrated ability to translate business needs into functional requirements and solution designs for commercial sales and service/field service enablement platforms, working effectively with product owners and delivery teams.



Nice-to-haves

MBA or advanced degree.

Experience with commercial sales and service/field service platforms (e.g., Salesforce Sales/Service Cloud & Field Service, Microsoft Dynamics 365 Sales/Customer Service/Field Service, ServiceNow CSM/FSM) and common integration patterns (ERP, PLM, eCommerce, CPQ, asset/parts).

Hands-on knowledge of MedTech/Medical Device service models (capital equipment and/or consumables), including installed base management, RMAs/returns, loaners, calibration, and depot repair.

Familiarity with regulated environments and quality systems relevant to medical devices (e.g., complaints handling, CAPA, change control) and how they intersect with commercial/service processes.

Service revenue growth experience (service offers, pricing, entitlements, renewals, warranty optimization, attach rate improvement) and customer experience improvement.

Remote service and connected devices (IoT/telemetry), predictive maintenance, and digital/AI enablement for service operations.

Service analytics and reporting (first-time fix, MTTR, utilization, parts fill rate, backlog, NPS/CSAT).

AI and automation use cases in CRM (NBA, recommendations).
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