Position: Sr. Product Development Engineer - Mechanical

Position type: Full-time - Onsite

No relocation reimbursement

Department: Drug Delivery Programs

Location: Irvine, CA

Hiring Manager: Director of Drug Delivery Programs

Position status: Exempt

As a key member of our Drug Delivery Programs team, the successful Senior Product Development Engineer is responsible for providing mechanical design engineering technical leadership on cross-functional product development teams during the pre-concept, development, design, test and documentation for manufacture of new and improved disposable medical and surgical devices, instruments or related products. The Senior Product Development Engineer is responsible for comprehensive technical knowledge of product development, transfer to manufacture, and supporting the regulatory approval process. Senior Product Development Engineer will have previous direct experience in the complete development life cycle from feasibility through commercialization and a strong character to drive projects to completion.

RESPONSIBILITIES

Responsible for the development products through planning, development, test, verification, optimization, human factors, clinical validation, transfer to manufacture, and familiarity with the regulatory approval process (concept to commercialization).
Provides in-depth knowledge of mechanical design, technical requirements and design & development lifecycle knowledge.
Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors.
Analyzes test data using statistical tools, performs in-depth interpretation of results, and generates detailed technical reports.
Conducts research and development of equipment design, tooling/fixture design and manufacturing processes for new production technologies and methods.
Collaborates with Quality Team to ensure procedures and methods to ensure quality standards are met and maintained throughout the development cycle.
Applies creativity and ingenuity to design an innovative system that can be delivered within program constraints.
Ensures that mechanical designs are correct, efficient, safe, robust, and ready for regulatory review or customer scrutiny.
Works with program managers, and other senior technical staff, to ensure that mechanical and/or systems requirements are clearly articulated.
Oversees the design/implementation of mechanical systems/subsystems from concept phase through design transfer and product launch.
Responsible for performing various statistically driven studies and analysis (such as DOEs , ANOVAs and Regression tests)
In a non-supervisory capacity, provides coaching, and guidance regarding project tasks to other engineers and technicians.
Prepares documentation to support quality system for design functions (project plans, design input, risk assessment, test protocols and reports, drawing specifications, etc.)
Drives mechanical project timelines and resource needs for device projects.
Assists in selection and performance in vendor management activities when required.
Performs other duties as they are identified to support cross-functional teams.

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.

BASIC QUALIFICATIONS/REQUIREMENTS

B.S. Degree in Mechanical Engineering with a minimum of 7 years design/development experience of combination products or M.S. degree in Mechanical Engineering with a minimum of 5 years design/development.
Demonstrated application of risk management through the product development life cycle.
Ability to formulate verification/validation test methods, protocols and reports.
Advanced SolidWorks experience and ability to create solid models and engineering drawings with a focus on manufacturability and automation.
Creative problem solving and conduct failure analysis and identify critical components.
Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate with people at all levels of the organization and lead with influence.
Proactive, forward-thinking, and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines.
Ability to handle multiple projects and priorities with exceptional organizational and time management skills.
Experience in injection molding and complex mechanisms.

PREFFERED QUALIFICATIONS

Working knowledge of Medical Device Development Life Cycle and Manufacturing from concept to commercialization.
Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.
Directs contribution to all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.e., 510k, De Novo 510K and PMA).
Design experience with autoinjectors and/or other precision drug delivery technologies.
Familiarity with compressed gases.
Good Project Management skills.
Experience with statistics and DOE techniques.
Familiarity with domestic and international regulations and industrial guidance documents (e.g., ISO, FDA guidance and CE Mark requirements).
Experience in computational fluid dynamics and FEA simulation.

Company Description

Altaviz is a global medical device company located in Irvine, California dedicated to empowering surgeons, clinicians, and patients with new, innovative, highly innovative products to improve patient safety while enhancing treatment efficiency and accuracy. Founded in 2012 with the vision to introduce game-changing innovative products backed by patent-protected technologies that offer elegant solutions to the challenges of patient care, Altaviz is focused on building a reputation as a market leader in the design and manufacture of novel single-use devices and instruments.

Our families of devices released and currently in development simplify the process of preparing for and executing treatment procedures while enhancing procedural safety profiles with device ease-of-use improvements reducing the occurrence of errors.

Game-Changers Work Here

Altaviz Game-Changers discover creative and innovative ways to enhance our customers' skills and abilities to improve healthcare. We are building a team of bold and inspired employees to continue our vision. Are you ready to change the game? Join our team and make a difference.

altaviz, llc

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