Research & Development Engineer/Senior Research & Development Engineer

OsteoRemedies, LLC

Memphis (TN)

Hybrid

USD 120,000 - 170,000

Full time

3 hours ago

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Job summary

OsteoRemedies, LLC is seeking an experienced Product Development Engineer in Memphis to lead the design, development, and launch of innovative medical devices. The role requires 5–10 years in product development for medical devices, technical leadership, and collaboration with surgeons, suppliers, and cross-functional teams.

The position emphasizes rigorous design controls, V&V, manufacturing transfer, and lifecycle management, with a fixed hybrid work arrangement (M-TH onsite, Fri remote).

Qualifications

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering or related field.
5-10 years of product development experience in medical devices.
Ability to independently lead projects and design activities.
Proven history of launching medical devices through complete lifecycle.
Strong understanding of Design Controls, V&V, Manufacturing Transfer and DFМ.

Responsibilities

Lead product development projects from concept through commercialization.
Plan and execute complex engineering projects with minimal supervision.
Translate clinical needs into product requirements and designs.
Lead cross-functional teams across engineering, QA, regulatory, clinical, operations and marketing.
Identify risks and develop mitigation strategies to meet timelines.
Drive supplier interactions and manufacturing transfer to production.

Skills

Product development leadership

Medical device design

Design for Manufacturability

Design Controls

V&V planning

Supplier management

Cross-functional collaboration

Technical communication

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Related engineering discipline

Tools

SolidWorks

Minitab

Office suite

Job description

Department: Research & Development (R&D)

Reports To: VP of Scientific Affairs

Location: Memphis, TN (Fixed Hybrid: M-TH onsite; Fri remote)

Title will be commensurate with experience.

Position Summary

We are seeking an experienced and highly motivated Product Development Engineer to lead the design, development, and commercialization of innovative medical devices. The ideal candidate will have 5-10 years of progressive product development experience within the medical device industry and a proven track record of successfully bringing products from concept through commercial launch.

This role requires strong technical leadership, the ability to independently drive complex projects with minimal supervision, and direct engagement with surgeons, customers, suppliers, and cross-functional teams. The successful candidate will possess deep knowledge of design controls, verification and validation activities, manufacturing transfer, and quality system requirements applicable to medical device development.

Key Responsibilities

Lead product development projects throughout the entire product lifecycle, from concept generation and feasibility through design, verification, validation, manufacturing transfer, and commercialization.
Independently plan, execute, and deliver complex engineering projects with minimal supervision.
Translate customer and clinical needs into product requirements, design concepts, and technical solutions.
Serve as the technical lead on cross-functional development teams, coordinating activities across engineering, quality, regulatory, clinical, operations, and marketing functions.
Identify project risks and develop mitigation strategies to ensure successful project execution.

Customer and Clinical Engagement

Regularly interact with surgeons, healthcare professionals, and other customers to gather insights, define unmet needs, evaluate concepts, and support product adoption.
Participate in customer visits, cadaver labs, procedure observations, and product evaluations to drive user-centered product development.
Present technical updates and design concepts to internal and external stakeholders.

Supplier and Vendor Management

Lead technical interactions with third-party vendors, development partners, contract manufacturers, and suppliers.
Define technical requirements and ensure supplier deliverables meet project objectives, timelines, and quality standards.
Support supplier selection, qualification, and ongoing technical management.

Design, Verification, and Validation

Develop and review engineering specifications, design documentation, risk analyses, test methods, and protocols.
Lead design verification and validation activities to demonstrate compliance with user needs, intended use, and regulatory requirements.
Ensure adherence to design control processes and applicable standards.
Collaborate with quality and regulatory teams to support submissions and compliance activities.

Manufacturing Transfer and Commercialization

Lead manufacturing transfer activities from development into pilot and commercial production.
Partner with manufacturing teams to optimize product designs for manufacturability, quality, reliability, and cost.
Resolve technical issues arising during scale-up and production launch.
Support post-market activities, including product improvements, investigations, and lifecycle management.

Required Qualifications

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related engineering discipline.
5-10 years of product development experience, preferably within the medical device industry.
Demonstrated ability to independently lead projects and design activities without regular supervision.
Proven history of successfully leading and launching medical device products through the complete product lifecycle.
Strong understanding of:
Design Controls (21 CFR Part 820 and applicable regulations)
Verification and Validation (V&V)
Manufacturing Transfer and Process Development
Design for Manufacturability (DFM)
Experience interacting directly with surgeons, physicians, and healthcare professionals.
Experience leading technical relationships with suppliers, contract manufacturers, and development partners.
Strong problem-solving, analytical, and decision-making skills.
Excellent written, verbal, and presentation communication skills.
Demonstrated ability to manage multiple projects and priorities while working independently and showing initiative.
Ability to perform effectively in a fast-paced environment where priorities may shift rapidly and aggressive timelines must be met.
Must be legally authorized to work in the United States and not require current or future sponsorship for employment visa status (e.g., H-1B).
Must be able to provide reliable transportation to and from the work location. Relocation assistance and housing are not provided.
Ability and willingness to travel domestically and internationally up to 20% of the time. Must be capable of traveling independently and maintaining all required travel documentation.

Preferred Qualifications

Master's degree in Engineering or a related technical discipline.
Minimum undergraduate GPA of 3.5 preferred.
Experience in orthopedic, spine, sports medicine, trauma, surgical, cardiovascular, or other regulated medical device markets.
Proficiency with Microsoft suite of products
Experience with CAD and 3D design software such as SolidWorks or equivalent.
Knowledge of Minitab or other statistical analysis software.
Working knowledge of FDA Quality System Regulations, ISO 13485, and ISO 14971.
Knowledge of human anatomy and its application to surgical procedures and medical device design.
Experience supporting product commercialization and global regulatory submissions.

Core Competencies