Position Description : SUMMARY : Nvision is seeking a highly skilled and experienced Medical Device Engineer to join our team. The successful candidate will be responsible for designing and developing medical devices and ensuring they meet all relevant regulations and quality standards.
DUTIES AND RESPONSIBILITIES :
- Design and develop medical devices, including concept development, design, and prototyping
- Conduct risk analysis and ensuring compliance with all relevant regulations and quality standards
- Collaborate with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs
- Participate in the design and execution of experiments and tests to evaluate device performance
- Analyze test results and making design modifications as necessary
- Develop and review technical documentation, including design and development plans, test protocols, and reports
- Maintain a thorough understanding of industry trends, technologies, and regulations
- Provide technical support to manufacturing and quality assurance teams
- May perform other duties and responsibilities as assigned or directed
- 3-10 years experience in implant design and development
- Prefer foot and ankle implant design experience
- Need Solidworks experience
- Experience with 510k submission requirements
- Mechanical or Biomedical engineering degree
- Must work on site here in San Antonio
SUPERVISORY RESPONSIBILITIES :
This job has no supervisory responsibilitiesQUALIFICATIONS :
Strong knowledge of medical device regulations and quality standards, including FDA and ISO requirementsExperience with medical device design and development processesStrong analytical and problem-solving skillsExcellent communication and interpersonal skillsDetail-oriented and organizedExperience with CAD software and other engineering toolsCOMPETENCIES :
Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforceEthics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational valuesCustomer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitmentsDependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate planInitiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when neededMotivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goalsOrganizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversityPlanning / Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plansStrategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditionsTeamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeedTechnical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with othersEducation and Experience :
Bachelor's degree in engineering, biomedical engineering, or a related fieldProven experience as a medical device engineer or in a related fieldPHYSICAL DEMANDS AND WORK ENVIRONMENT :
Ability to stand or sit for long periods of timeAbility to lift up to 50 pounds.Occasional exposure to bloodborne and airborne pathogens or infectious materials along with occasional exposure to cadaveric specimensThe above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
