Engineering Project Manager - Medical Devices

Sacbar; Santa Barbara (CA); On-site; USD 92,000 - 167,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Annual Bonus

Paid Time Off

Job summary

Arthrex is seeking an Engineering Project Manager within the Global Service and Repair Organization to support cross-functional new product development programs from concept through commercialization. You will partner with engineering, manufacturing, quality, regulatory, and business stakeholders to deliver life-changing medical technologies on time and within budget.

The role emphasizes collaboration, design controls, risk management, and adherence to FDA/ISO guidelines in a fast-paced

Qualifications

• BS Engineering is required; Biomedical, Electrical, or Mechanical preferred.
• 2 years of relevant experience in engineering/project management.
• Knowledge of FDA and ISO guidelines for medical devices is preferred.

Responsibilities

• Manages subsidiary-based and global projects within new product development.
• Develops project objectives with senior management and key stakeholders.
• Determines project schedule, time requirements, and resource needs.

Skills

Project management

Cross-functional leadership

Regulatory compliance

Design controls

Medical device knowledge

Risk management

Communication

Budgeting

Education

BS Engineering

2 Years of Relevant Experience

Job description

Requisition ID: 67733

Title: Engineering Project Manager - Medical Devices

Salary Range:

Salary Minimum: $92,000.00

Salary Maximum: $167,000.00

Are you an engineer who enjoys bringing innovative ideas to life while leading teams through complex development challenges? At Arthrex, a global leader in orthopedic medical devices and medical education, we're seeking an Engineering Project Manager within the Global Service and Repair Organization to support cross-functional new product development programs from concept through commercialization. In this role, you'll partner with engineering, manufacturing, quality, regulatory, and business stakeholders to deliver life-changing, service ready medical technologies on time, within budget, and in compliance with industry regulations. If you're a collaborative problem solver who thrives in a fast-paced environment and wants to make a meaningful impact on patient care, you'll find a rewarding career at Arthrex, where our mission is Helping Surgeons Treat Their Patients Better.

Essential Duties and Responsibilities:

• Manages subsidiary-based and global projects/programs within the scope of the new product development
• Develop project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholders
• Determines project schedule by studying project plan and specifications, calculates time requirements, identifying and sequencing project elements and discreet tasks
• Maintains project schedule by monitoring project progress, coordinating activities, and resolving risks or obstacles
• Determines project responsibilities by identifying project phases and elements, requesting and allocating resources as necessary
• Ensure design history file facilitation for assigned projects, adhering to Arthrex design control procedures.
• Ensure project progresses within the boundaries of the approved scope. Manage the scope of the project and guarantee scope changes are properly documented and implemented.
• Identify opportunities for improvement within the Project Management Governance and Design Control Process to improve speed to market.
• Monitor resource capacity within the New Product Development groups and cross-functional resources and communicate constraints or needs to senior management.
• Help facilitate, with interdepartmental managers, the availability, assignment, and accountability of downstream resources and technology
• Help facilitate project, program and portfolio status to management and key stakeholders with applicable metrics and project constraints.

Knowledge:

• Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards.

Reasoning Ability:

• Solves routine problems of limited scope and complexity following established policies and procedures.

Skills:

• Ability to effectively communicate project planning requirements, including task elucidation, duration, and resource requirements.
• Strong strategic thinker, excellent collaboration and communication skills, careful attention to detail.
• Ability to balance business and technical Ability to effectively communicate project planning requirements, including task elucidation, duration, and resource requirements.
• Strong strategic thinker, excellent collaboration and communication skills, careful attention to detail.
• Ability to balance business and technical risks while remaining compliant with internal systems.
• Awareness of full life cycle development of medical devices, which includes initiation, design, development, execution, and sustaining.
• Working knowledge of medical device regulations and associated quality systems, particularly design controls and risk management.
• Manufacturing process knowledge preferred.
• Awareness orthopedic surgery principles, theories, and products preferred.
• Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred.
• Strong communication skills and accountability to project deliverable timing and budgets required.
• Ability to confidently lead complex, cross functional teams independently.
• Demonstrable bias for action.
• Strong desire and proven ability to learn quickly.
• Continuously seeking ways to improve complex systems of people and processes, while eliminating waste.

Education/Experience:

• BS Engineering required. Biomedical, Electrical, or Mechanical preferred
• 2 Years of Relevant Experience

Reasoning Ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

• Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Arthrex 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 Lunch
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Paid Sick Leave
• 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.