Engineer - CMF at OsteoMed in Addison, Texas

Posted in Manufacturing 2 days ago.





Job Description:


OsteoMed


Engineering
Addison, TX, USA
Full Time
Worksite - Addison
Medical, Vision, Dental, 401(k) match, Paid Parental Leave, Paid Time Off, Tuition Reimbursement Program, + much more


About Us

OsteoMed is a leading global innovator, developer, manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments.

Our mission is to improve patient outcomes through the design, manufacture, and service of high quality, innovative and cost effective surgical products.

We value teamwork based on trust, respect & communication. We hold our employees accountable by empowering them and recognizing their initiatives. If you are looking for a company who values its employees, apply today!

Engineer (CMF)

Responsible for supporting the development of new products from concept through commercialization as part of a cross-functional development team. This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation.

Duties/Responsibilities
  • Performs routine engineering assignments or related tasks, which are typically of smaller scope or a portion of larger projects.
  • Solve problems and design experiments with some assistance. Expected to make suggestions or improvements based on recent technical knowledge and help implement the improvements.
  • Resolve technical issues within the scope of one's core educational expertise with assistance and monitoring from more experienced staff.
  • Manage an entire project of small scope or portions of projects with limited supervision. This includes:
  • Lead efforts to establish resource estimates, timelines, and schedules for new development projects with some assistance.
  • Interface with project team members and other support personnel.
  • Direct project team members and other support personnel with assistance.
  • Contribute to project risk management.
  • Organize and prepare internal data and documentation according to company procedures and policies. Also assists in the preparation and presentation of materials for technical reviews.
  • Assists in conducting cadaver labs and may attend surgeries in hospitals with other OsteoMed personnel.
  • Complete design concepts, prototypes, analytical models, validation parts, documentation, and all other aspects of assigned projects according to FDA and ISO regulations and OsteoMed SOP's.
  • Create design inputs from user needs and marketing requirements.
  • Prepares engineering documentation including: engineering drawings, test plans, manufacturing instructions, design verification and validation protocols and reports, engineering change notices, artwork specifications, and other supporting engineering documents with supervision and assistance from others.
  • Lead in identifying and mitigating safety and efficacy risks.
  • Develop knowledge of anatomy, physiology, mechanics, kinematics, patent landscape, and other technical fields that are related to your specialization area.
  • Other responsibilities assigned by supervisor and including attending trade shows and corporate functions associated with role as an engineer.
  • All other duties as assigned.

  • Qualifications
  • BS degree in Biomedical or Mechanical Engineering with a minimum of 2 years of experience in related field, or MS or MEng degree in Biomedical or Mechanical Engineering.
  • Proficient in SolidWorks or equivalent modeling software and Microsoft Office products.
  • Versed in Computational Stress Analysis, GD&T, Tolerance Studies, Design Control, & Technical Writing.
  • Able to Lead FMEA sessions.
  • Understands descriptive statistics and is capable of performing basic statistical analyses.
  • Understands common engineering materials and material properties.
  • Ability to internally communicate technical or project management results and issues, both verbally and in written form. With supervision, may externally communicate technical information to suppliers or contractors.
  • Able to work with project team members in a productive manner, identify conflicts or issues, and facilitate resolution.
  • Basic understanding of how OsteoMed products are used and how to develop a business case for NPD projects.
  • Able to build trust among team members and communicate openly and effectively. Driven to fulfilling assigned team goals.
  • Possess a basic knowledge of project management principles.
  • Ability to give presentations to small audiences.
  • Basic knowledge of applicable ISO and CFR regulations preferred.Able to frequently lift up to 25lb and occasionally up to 50lb.
  • Occasional travel (5-10%) may be required.
  • Able to properly wear PPE (Personal Protective Equipment) required for the area of operation such as gloves, ear protection, eye protection, smocks, etc.
  • Able to obtain and maintain required credentials in order to access cadaver lab and hospitals.

  • While performing the duties of this job, the employee is or may be regularly required to sit and stand for sustained periods of time; reach by extending hand(s) or arm(s) in any direction; walk; Pushing; lift by raising objects from lower to higher or moving horizontally; finger (picking, pinching, typing or otherwise working, primarily with fingers rather than the whole hand as handling; grasp; feel; talk (express or exchange ideas by means of spoken word which must convey details or important spoken instructions to others accurately; hear (perceiving sounds at normal speaking levels with or without correction; repetitive motion of wrists, hands or fingers.

    For more than two decades, OsteoMed has remained sharply focused on meeting the needs of surgeons and their patients by rethinking clinical possibilities with a focus on procedural efficiency, efficacy and uncompromised quality.

    A highly nimble and responsive company, OsteoMed is a leading global innovator, developer, manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments.

    Our success is driven by the ability to quickly develop and deliver innovative, quality products focused on improving patient outcomes and offer technically advanced, simple and cost-effective solutions for surgeons, hospitals and patients. Our state-of-the-art manufacturing facility and world headquarters is located in Dallas, Texas. This allows us to offer remarkable responsiveness to those who count on our products.

    OsteoMed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability. PI138893741