Must have leadership experience, as well as, medical device experience- including plates and screws.
Proficient in SolidWorks, MS products (Word, Excel, Project) Minitab, and PDMWorks. Strong leadership skills. Good problem solving skills. Good organizational skills.Good communication skills. Financial Management At least ten years of experience in the design and development of medical devices with at least four years of supervisory experience leading a team of engineers. Trained and experienced Project Manager per PMI.
Summary: Lead, manage and ensure the successful completion of the
development of mechanical and electro-mechanical medical devices as
defined by the company. This includes mentoring team performance and
ensuring that the Product Development Team is operating effectively to
achieve set objectives. Participates in cross-functional development
teams and collaborates with the business leadership to execute projects
from concept through commercialization. Manages internal and external
design, development, testing, and manufacturing suppliers. Defines and
manages the product development scope of work and ensures product
safety, quality, performance, and cost requirements are met. Creates and
manages a detailed project schedule for engineering development and
product launch activities.
Duties And Essential Job Functions
a team of biomedical, mechanical engineers and designers in developing
and bringing to market, new innovative medical products, that provide
true advances in clinical outcomes.Participate in the evaluation of new concepts presented to the company by surgeons or other company employees.Assure compliance to FDA and ISO regulations and the company SOP’s.Establish and maintain project schedules.Review designs for feasibility, accuracy and technical soundness.Lead other engineering personnel in formulating project plans, designs, cost estimates, and specifications.Define and implement testing requirements associated with projects.Assure timely, effective, and within budget completion of assigned projects.Analyze and recommend resources needed to meet project goals.Assure
proper preparation of documentation as required per project plans
including: engineering drawings, test plans, manufacturing instructions,
design verification and validation, engineering change notices, artwork
and other supporting engineering documents.Working with
manufacturing, supply chain and quality assurance, reviews and monitors
quality and process improvements for new product development.Identify new design methods and materials to improve productivity and competency within Product Development team.Author and administer ISO Design Controls as well as FDA documentation requirements.Assist in generating annual department budget and objectives.Identify the need for and hire new personnel.Train new department employees on department SOP’s, DOP’s and any other aspect that will affect their responsibilities.Administer
personnel functions, including performance management, hiring, and
mentoring of engineers and support personnel in product development
team.Contribute to the intellectual property position of the company via invention and patent applications.Maintain
basic knowledge of competitive technologies, in addition to medical,
clinical, technical and biomedical developments in the field.Maintain communications with customers and suppliers.Assist and support other employees and teams as necessary.Other
responsibilities assigned by supervisor including attending trade
shows, surgery and other corporate functions associated with role as an
Engineering Manager for Product Development.Occasional traveling required (<5%)
4 year Biomedical, Mechanical Engineering or Electrical Engineering degree. MS in Engineering preferred. Design for Six Sigma Certification a strong plus.
Able to frequently lift up to 25lb and occasionally up to 50lb. Able to wear required PPM for working with biohazardous materials in cadaver lab or Operating Room settings.