Senior Device Engineer

Kindeva Drug Delivery•Maryland Heights, MO

5d•Onsite

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make Works as a device engineering team lead or member/lead of cross-functional teams, as well as independent contributor throughout the Combination Product Life Cycle process. Leads or participates in cross-functional teams for design changes, design transfer activities, continuous improvement projects, investigations, risk assessments and protocol execution. Responsible for device life cycle management of on-market combination products and implementation of new products. Develops Design History File documents, Risk Management documents, change management technical impact assessments, test plans/ protocols, test method validations, and data analysis. Leads design changes from initiation through design transfer. Performs or oversees engineering, design, and development work. Develops design concepts/ideas for product improvements, fixtures, gages, and test methods. Develops prototypes of design concepts for engineering testing and evaluation. Generates or reviews/approves SOPs, test protocols, engineering test reports and provides laboratory oversight as needed. Responsible for adhering to design controls and documenting all product development work and updates in a Design History File.

Requirements

Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field
B.S. Degree in Engineering discipline with 7 - 9 years experience
M.S. Degree in Engineering discipline with 5 - 7 years experience
Ph.D. in Engineering discipline with 3 - 5 years experience
(Biomedical Engineering or Mechanical Engineering preferred)

Nice To Haves

Thorough understanding and in-depth knowledge of FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30, ISO 13485 and ISO 14971 and related standards, and EU Medical Device Directives
Understanding of production and production systems in a GMP regulated environment
Strong technical project management, critical thinking, and problem-solving skills. Proficient in Smartsheet or MS Project.
Experience analyzing complex issues for patient/user impact
Understanding of Human factors and usability engineering
Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.)
Proficiency in SolidWorks design software, Mathcad, MindManager, and other general computer software such as word processing, spreadsheets, presentations, flow charts, etc. Strong laboratory skills such as component inspection or failure analysis, mechanical testing, etc. with a good understanding of GMP documentation and data integrity requirements.
Strong mathematical, analytical, and reasoning skills
Strong innovation skills and creativity astuteness
Strong teamwork and organizational skills
Strong written and oral communication
Knowledge of Design for Reliability and Manufacturing (DRM) and robust device design practices
Ability to prioritize multiple responsibilities and to work on multiple complex technical projects simultaneously
Experience with FDA investigators and other global regulatory agencies in the front room or providing back room support

Responsibilities

Leads or participates in design control, change management and risk management activities related to the combination device, design and manufacturing process ensuring compliance to all applicable regulations including FDA Regulation and Guidance for Combination Products
Perform Quality Risk Assessments
Performs or oversees biomedical/mechanical engineering design and development work, including design changes and product improvements, Geometric Design and Tolerancing, drawings, tolerance stacks, risk analyses, and engineering analyses. Establishes or reviews/approves specifications and inspection requirements for components, products, and processes.
Develops prototypes of design concepts for engineering testing and evaluation
Creates or reviews/ approves SOPs, Job Aids, test protocols, reports and risk-based plans for verification and validation testing.
Develops/ approves/maintains DHF documents and rationales in support of design changes, design transfer, investigations, information requests, and product life cycle
Supports Manufacturing, QCD Lab, QDS Lab, Quality Engineering, and Quality Assurance with investigations and the qualification of new material/ processes/ equipment to assure reliability requirements are met. Participates in or leads CAPA investigations.
Provides input and technical support for device changes, document updates, process changes, risk management. Performs assessments for change control and may represent group and product on change control review committee. Accountable for change management projects or investigation actions related to the device, design, manufacturing process, or new/updated standards and regulations.
Develops test methods, fixtures, gages, challenge samples, limit samples, simulation devices, and engineering prototypes of design concepts
Develops or collaborates on and adheres to project plans, timelines, and budgets
Liaison with internal production sites, quality, regulatory R&D, and Tech Transfer/Launch Teams
Establish and maintain relationships with production sites and key stakeholders
Technical oversight of other engineers
May require management of cross-functional teams and indirect reports
Reports and escalates to leadership as appropriate
May provide training for new hires or contractors and may oversee work conducted by contractors or lab technicians.
Other duties as assigned