- Professional
- Office in Irvine
Basic Function:
We are seeking an R&D Project Manager to join our team. The successful candidate will have at least 5 years of experience managing R&D projects, working with cross-functional teams, using global frameworks, managing stakeholders, and presenting regular status updates.
Responsibilities:
As the R&D Project Manager in our Bracing Division, you will be responsible for guiding multidisciplinary teams in the development and improvement of bracing medical devices. Your primary focus will be on new product development (NPD) and ongoing process and product improvements. You will work closely with cross-functional partners located across multiple time zones—including engineering, regulatory, quality, manufacturing, marketing, and clinical affairs—to ensure projects are delivered on time, within budget, and to the highest quality standards.
Lead and manage medical device R&D projects from concept through commercialization, applying best practices in project management, product development, and continuous improvement.
Coordinate project teams across global locations, respecting time zone differences and ensuring effective communication and collaboration.
Use global frameworks and methodologies to manage projects.
Develop project plans, timelines, budgets, and resource allocations in alignment with business goals.
Facilitate cross-functional meetings to drive project progress, resolve issues, and maintain accountability.
Monitor project performance using established metrics and KPIs; identify risks and implement mitigation strategies proactively.
Support regulatory submissions and product documentation, ensuring compliance with relevant medical device standards and regulations (e.g., FDA, ISO 13485).
Champion continuous improvement initiatives, including process optimization, cost reduction, and product enhancements.
Maintain clear and thorough records of project activities, decisions, and changes.
Communicate project status, milestones, and deliverables to internal and external stakeholders at all levels.
Participate in technical reviews, design verification and validation activities, and risk management analysis.
Coordinate with manufacturing and supply chain teams to support product launch and scale-up.
Adhere to Company’s safety rules.
Adhere to Company Values – Honesty – Frugality - Courage
Perform other duties as requested.
Exercises good use of company funds and property within the set guidelines. Maintains an honest and professional attitude as the company’s representative always.
Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards.All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur. Training takes place in the Onboarding process and in New Employee Orientation. More specific Quality training is job specific.
All training related to the quality management system is done in accordance to the Training Management Process (PR-00042).
Qualifications:
Required:
Bachelor’s degree and minimum 5 years of hands-on experience in R&D project management within a medical device company, preferably with a focus on orthopedics.
Demonstrated success in leading cross-functional teams and managing complex projects from inception to launch.
Strong understanding of medical device development processes, including design controls, risk management, and regulatory compliance.
Excellent organizational, communication, and leadership skills.
Ability to manage multiple priorities and adapt to changing business needs.
Comfort with travel up to 25%, both domestically and internationally.
Proficiency with project management software (e.g., MS Project, JIRA) and collaborative platforms (e.g., Teams, Zoom).
Strategic mindset with attention to detail and a commitment to quality.
Preferred:
Bachelor’s degree in engineering (mechanical, biomedical, materials, or related field) or other technical discipline.
PMP and experience with Agile methodologies is preferred
Experience collaborating with remote teams and managing projects across time zones.
Knowledge of orthopedic device technologies, materials, and clinical applications.
Background in continuous improvement, process engineering, or operational excellence.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
The US base salary range for this full-time position is $80,061 - $98,887 + bonus + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Össur is a leading global provider of prosthetics and bracing and supports solutions.
Embla Medical is an equal opportunity employer and makes employment decisions on the basis of merit. We want to have the best available individual in every job.
Embla Medical's equal opportunity policy prohibits all discrimination (based on race, color, creed, sex, religion, marital status, age, national origin or ancestry, physical disability, mental disability, military service, pregnancy, child birth or related medical condition, actual or perceived sexual orientation, or any other consideration made unlawful by local laws around the world).
Embla Medical is committed to complying with all applicable laws providing equal employment opportunities. This commitment applies to all individuals involved in the operations of Embla Medical and prohibits discrimination by any employee of Embla Medical, including supervisors and co-workers.
Important Warning: Beware of fraudulent recruiters impersonating our company. Please take extra caution when asked for any sensitive personal information, such as social security numbers or bank account details. We will never ask you for any form of payment during the recruitment process. Please make sure you refer to our official website.
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