- Develop new/innovative process technology to anticipate the needs of the customer and maintain competitive in the orthopedic/podiatric medical device industry
- Perform market research to devise solutions to orthopedic/podiatric problems; including performing customer inquiries and analyzing existing products
- Participate in product development including concept, generation, decision matrices, prototype, manufacture, and associated metrics
- Provide expert product leadership for the new development projects assigned; this includes an unrelenting attention to minimizing project delays and resource overages
- Provides technical guidance to junior engineers throughout the entire design and development process
- Perform research and qualification testing utilizing axial, torsional, compression, and other test methods
- Prepare product reports by collecting, analyzing, and summarizing information and trends.
- Assist in the 510(k) application process by providing official test batch and qualification information for FDA review
- Communicate with vendors regarding outsourced manufacturing and serve as an engineering point of contact
- Provide technical guidance and support to manufacturers in an effort to maintain quality of work
- Be aware of and comply with regulatory requirements that are applicable to Trilliant Surgical, including but not limited to the MDD, CMDR, 21CFR820 & other regulations as applicable.
- Maintain equipment by coordinating maintenance and repair services and following manufacturer's instructions and established procedures
- Train applicable staff on testing and manufacturing processes associated with each company product
- Participate in performance improvement activities, utilizes resources efficiently and effectively takes responsibility for own learning needs
- Create design inputs from user needs and marketing requirements, work with surgeons or teams of surgeons to connect clinical experience with design specifications.
- Create detailed and accurate project plans and estimates for resources - determine tasks, budget, labor, materials, and time required to complete projects
- Lead in identifying and mitigating business risks and share best practices with other appropriate staff across all departments.
- Lead in the preparation and presentation of materials for internal or external technical reviews.
- Leads and provides guidance to junior engineers in early freedom to operate (FTO) reviews
- Leads preparation of engineering documentation including: engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, and other supporting engineering documents
- Review and approve engineering documentation prepared by junior engineers including: engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, and other supporting engineering documents
- A degree in Mechanical or Biomedical Engineering (other Engineering or technical degree is acceptable with prior medical device development experience)
- 8 years of experience in the orthopedic medical device industry (e.g. podiatric, spine, upper extremities, and joint replacements including shoulders, knees and ankles, and) or a combination of 6 years of work experience and an advanced degree
- Experience mentoring and training junior/associate engineers
- Must be proficient in general computer programs such as Microsoft Office, and CAS software
- Must be proficient in CAD software such as SolidWorks (preferred), Creo, Autocad, or similar for modeling and drawing creation.
- Strong planning, technical, and problem solving skills
- Ability to prioritize and multi-task with little supervision
- Previous work experience should demonstrate "out of the box" thinking, strong conceptual, design, and analysis skills, self-motivation, flexibility, detail-oriented work style, professional appearance and attitude, and ability to effectively communicate with customers/clients at all levels.
- Must have strong understanding of engineering level mathematics and physics
- Ability to understand and create engineering schematics
- Knowledge of FDA regulations (21CFR 820), ISO standards (ISO 13485), MDD, CMDR and other regulations as applicable.
- Must have legible handwriting
- Certified six sigma green belt
- Experience with GD&T training and familiarity with ASME Y14.5
- Ability to travel via automobile and/or airplane as needed (travel out of the Houston metropolitan area will be needed) - Typically once a month or once every two months
- Ability to tug, pull, or lift up to forty (40) pounds
- Ability to sit or stand for extended periods of time
- General office environment. The office is clean, orderly, and properly lighted and ventilated. Noise levels are considered low to moderate.
- Direct exposure to manufacturing equipment and hazards. Noise levels are considered moderate to high.
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal Services
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Sr. R&D Engineer - Houston, United States - Enovis
Description
Job Description:At EnovisTM we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.
Because that's how we change the lives of patients for the better. And that's how we create better together.
Position Summary
In an effort to facilitate the achievement of company goals, the Sr. R&D Engineer will design, test, and participate in manufacturing activities for company products. This includes but is not limited to interfacing with physicians and other customers to determine needs/requirements; creating prototypes, testing, and documenting test results; scheduling, coordinating, and managing multiple projects; and communicating with vendors to ensure product quality.
Essential Duties and Responsibilities
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
The following are the minimum qualifications that an individual will need in order to successfully perform the duties and responsibilities of this position. The individual may be required to demonstrate proficiency in some of these areas depending on the department and/or job functions assigned. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
In general, the following conditions of the work environment are representative of those that an employee in this position will encounter while performing the essential functions of this job. Reasonable accommodations may be made to allow differently able individuals to perform the essential functions of the job within the environment.
Watch this short video and discover what creating better together means to us at Enovis:
Our Enovis Purpose, Values and Behaviors on Vimeo
We offer a comprehensive benefits package which includes:
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit to learn more.
EQUAL EMPLOYMENT OPPORTUNITY:
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.
ABOUT ENOVISTM
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.
