Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer's quality specifications for each product we produce.

The Senior Project Manager / Product Development Engineer will be responsible for planning and executing projects for Avalign owned and contract developed devices (including the design, development and commercialization of surgical instruments and implants) and will serve as a subject matter expert providing oversight to peers with an emphasis on strong communication skills and customer advocacy.

Principal Accountabilities:

Key Responsibilities - Project Management

• Responsible for 1-4 projects at a time dependent on project size
• Leads cross-functional, multi-site and business unit project teams in a matrixed environment
• Leads, facilitates and coordinates all project activities to ensure projects are completed successfully in accordance with organizational goals, policies, and contractual terms and conditions
• Effectively manages customer expectations of products and services to support customer satisfaction
• Manages the scope of the project including priorities and any creep
• Creates project schedules with clear milestone targets and task responsibilities
• Proactively manages project risks identifying mitigation efforts and tracking resolution
• Effectively communicates with project stakeholders on status updates and appropriate escalation of project issues
• Accurately forecasts non-recurring engineering (NRE) efforts and creates project budgets for internal project charters and customer proposals
• Defines project resource requirements and coordinates across departments and business units to obtain sufficient resources
• Demonstrates leadership and influence in directing project activities
• Actively identifies and removes project barriers through conflict management, negotiation and creative problem solving
• Uses and creates corporate governance tools based on best practices and lessons learned

Key Responsibilities - Product Development:

• Leads technical activities in the commercialization of surgical instruments across various market segments (large and small joint orthopedics, spine, trauma, sports medicine, etc.)
• Champions all necessary design control documentation for developed products in accordance with quality systems & procedures to build electronic design history files (DHF) and Technical Files (TF) ensuring the safety and efficacy of devices
• Translates design requirements into concepts and formulates device specifications including drawings with critical to quality (CTQ's) features using 3D CAD software, product labels, and instructions for use (IFU's)
• Evaluates and applies appropriate engineering standards and best practices for intended use including material selection and strength and mechanical properties
• Responsible for risk management including hazard analysis and failure mode effect analysis for the intended use and design (uFMEA and dFMEA)
• Conducts and oversees all aspects of design verification and validation (V&V) including tolerance analysis, writing test protocols, managing testing with outside laboratories, evaluating and analyzing test results, and writing test reports and engineering rationales
• Collaborates with manufacturing engineers across business units for design feedback on features & benefits, design for cost (DFC), manufacturability (DFM), and inspection (DFI)
• Oversees manufacturing of prototypes, design transfer, and production to ensure the device meets the design intent and product specifications
• Supports QA/RA with post-launch compliance activities
• Supports business units and sales team in technical analysis and communication
• Conducts internal research and development to develop new and to improve existing proprietary technologies
• Provides product and technical support at Trade Shows
• Provides coaching, mentoring and training for peers
• Reviews and verifies work efforts of peers

Interactions:

• Reports to R&D Manager, Director or Vice President
• Internal (all Avalign business units)
• R&D: development, design control, resource management, project management and administrative
• Sales/Customer Service: customer requirements & strategic account management
• Operations: prototype needs, pre-production and design transfer, planning and monitoring production schedules
• Quality & Regulatory: design reviews and V&V activities
• Purchasing: prototype & service purchase orders
• External
• Suppliers: service RFQ's and design feedback, planning and monitoring schedules
• Customers: expectation management, status updates, design requirements & changes, deliverable approvals

Experience and Training Required to Perform Job:

• Bachelor of Science in relevant engineering field, Mechanical or Biomedical preferred
• A minimum of 8 years product development experience and a minimum of 5 years project management experience. A Master's degree in a relevant field of study may be substituted for direct experience.
• Prefer PMP certification through PMI
• Understanding of the medical device quality and regulatory environment, including but not limited to, FDA CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971
• Knowledge of common medical device manufacturing processes and methods is required
• Knowledge of industry recognized project management methodologies
• Proficiency with Microsoft Office, Project, CAD software (preference for SolidWorks), print reading and GD&T
• Understanding of basic anatomy and physiology and procedures for which products will be designed and developed
• Experience with electronic document control systems
• Ability to communicate complex technical knowledge in an effective manner, both written and oral
• Self-motivated individual capable of functioning in both independent and team settings
• Results oriented and able to work in a fast-paced environment to meet project and business goals

What You'll Enjoy:

• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Working for a thriving, performance-based company that values promoting from within and career advancement
• Temperature controlled environment
• Community involvement investing and giving back to the community
• Additional free resources such as travel assistance, EAP, etc.

Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Other details

• Pay Type Salary

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