Arthrex
Sr. Engineer I - Product Development - Trauma FL
Arthrex, Naples, Florida, United States,
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.Arthrex BenefitsMedical, Dental and Vision InsuranceCompany-Provided Life InsuranceVoluntary Life InsuranceFlexible Spending Account (FSA)Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)Matching 401(k) Retirement PlanAnnual BonusWellness Incentive ProgramFree, Onsite Medical ClinicsFree LunchTuition Reimbursement ProgramTrip of a LifetimePaid Parental LeavePaid Time OffVolunteer PTOEmployee Assistance Provider (EAP)Please note, most benefits are for regular, full time employees.All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.Arthrex, Inc. is a global medical device company leader in new product development and medical education in orthopedics. We are actively searching for an experienced Senior Engineer in medical device product development for the Trauma team. This engineer will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Excellent communication and interpersonal skills, five plus years of medical device design and development experience and a bachelor’s degree in Engineering are essential for this position. Experience in CAD software is also required. Project management experience strongly preferred. This position will be located at our Naples, FL campus. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.Essential Duties and Responsibilities:
Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations. Recommends alterations to development and design to improve quality of products and/or procedures. Determines budgets and timelines for assigned projects. Leads multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
Maintains design history file for assigned projects, adhering to Arthrex design control procedures. Provides Regulatory department technical support for assigned projects as needed. Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products. Supports Manufacturing to provide processing improvements. Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed. Determines necessity of testing and initiates testing of assigned products Reports progress and status of assigned projects on a timely basis.
May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required. Education/ Experience: 5 years of relevant experience required Bachelor’s degree in engineering required, preferably in Mechanical, Biomedical, or Electrical Engineering Skills: Knowledgeable of FDA and ISO guidelines for the development of medical devices required. Manufacturing process knowledge preferred. Project management and communication skills training preferred. Working knowledge of anatomy from an orthopedic standpoint preferred. Working knowledge of joint anatomy preferred. Proficiency in designing products using a 3D-CAD program.
Creo and/or SolidWorks experience preferable. Technical knowledge in development methodologies, design, and project implementation. Knowledge of orthopedic surgery principles, theories, and products. Historical perspective on orthopedic surgery principals, theories, and products preferred. Knowledge:Complete understanding and application of principles, concepts, practices, and standards.
Full knowledge of industry practices.Reasoning Ability:Develops solutions to a variety of complex problems.
May refer to established precedents and policies.Discretion/ Latitude:Work is performed under general direction.
Participates in determining objectives of assignment.
Plans schedules and arranges own activities in accomplishing objectives.
Work is reviewed upon completion for adequacy in meeting objectivesArthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free Onsite Medical Clinics Free Onsite Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations. Recommends alterations to development and design to improve quality of products and/or procedures. Determines budgets and timelines for assigned projects. Leads multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
Maintains design history file for assigned projects, adhering to Arthrex design control procedures. Provides Regulatory department technical support for assigned projects as needed. Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products. Supports Manufacturing to provide processing improvements. Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed. Determines necessity of testing and initiates testing of assigned products Reports progress and status of assigned projects on a timely basis.
May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required. Education/ Experience: 5 years of relevant experience required Bachelor’s degree in engineering required, preferably in Mechanical, Biomedical, or Electrical Engineering Skills: Knowledgeable of FDA and ISO guidelines for the development of medical devices required. Manufacturing process knowledge preferred. Project management and communication skills training preferred. Working knowledge of anatomy from an orthopedic standpoint preferred. Working knowledge of joint anatomy preferred. Proficiency in designing products using a 3D-CAD program.
Creo and/or SolidWorks experience preferable. Technical knowledge in development methodologies, design, and project implementation. Knowledge of orthopedic surgery principles, theories, and products. Historical perspective on orthopedic surgery principals, theories, and products preferred. Knowledge:Complete understanding and application of principles, concepts, practices, and standards.
Full knowledge of industry practices.Reasoning Ability:Develops solutions to a variety of complex problems.
May refer to established precedents and policies.Discretion/ Latitude:Work is performed under general direction.
Participates in determining objectives of assignment.
Plans schedules and arranges own activities in accomplishing objectives.
Work is reviewed upon completion for adequacy in meeting objectivesArthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free Onsite Medical Clinics Free Onsite Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.