Senior Engineering Manager - Product Development Design Engineering Mystic Pharmaceuticals

The position supports new product development by executing engineering tasks and collaborating cross functionally to bring new drug delivery systems into a production environment. Products include hand held mechanical unit dose drug delivery devices for ophthalmic, intranasal, and oral applications. This position requires a candidate with extensive product development experience in the medical device arena and will play a crucial role in the development of a rapidly growing engineering operation with responsibility for projects in engineering, design, process development, verification/validation testing, and document control.


You will be a part of the team responsible for ensuring the timely, cost responsible and ultimate successful delivery of the devices being developed. You will need excellent communication skills, project management skills and the ability to work in a corroborative atmosphere.


RESPONSIBILITIES:


Project Management

Actively participate in all phases of the product development process, from idea creation through to transfer to manufacture

Assist in defining product requirements, communicate and resolve technical issues, and create and present project reviews and updates

Monitor and report costs for design area and estimate cost affected by design. Recommend capital expenditure and production methods for existing or enhanced products or processes
Effectively collaborate with cross-functional team members comprised of quality, manufacturing, marketing, clinical, regulatory, and materials people to bring product from conception to production

Develop preproduction quality assurance processes used during new product development projects and design changes to existing products

Lead small one or two discipline project teams as needed to accomplish project objectives as well as provide supervision to technicians

Perform Risk Analysis


Product Design

Design plastic components for medical devices using SolidWorks, and FEA tools such as COSMOSWorks and Mold Flow

Designs will incorporate complex mechanisms, reliability, esthetics, ergonomics, human factors, and cost

Select sound techniques to solve problems and make recommend techniques to improve existing products/processes including recommendations of materials and process specifications

Work with suppliers and molders in the design of injection molded components.

Rapid prototyping, machined, and injection molded parts

Test, analyze, and solve engineering product development problems.

Assess designs for validity and conformance to specifications.


Documentation

Maintain product files and other relevant documentation to comply with quality standards

Documents design reviews, FMEA meetings, weekly meetings, and communication to suppliers.

Maintain drawings within the Device Master Record (DMR)

Revise drawings and documentation using the Change Control Documentation (CCD) process

Supply Regulatory department with technical assistance for Regulatory Submissions and inquires.


Other

Utilize engineering laboratory equipment, and assist in developing test methodologies and standards

Design/develop fixtures to aid in assembly and production

Perform other tasks as required


QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required


Bachelor's degree in Engineering is required

Minimum of 12 years related experience and/or training.

8+ years of industry experience in a medical product development and design environment

8+ years work experience as a Design Engineer utilizing design control procedures with medical products

6+ years experience with Solid Works including experience with surfacing techniques and advanced modeling

5+ years Project Management experience with medical devices required

This is a hands-on position and you must be currently and actively engaged in product development and have the ability to work effectively with small product design teams of 2 to 10 people.

Proven project management skills and experience, including design control procedures and Medical Device regulatory procedures.

Experience in performing FMEAs, verifications and validations for medical devices products and processes

Experience with products manufactured with annual volumes of 5,000 to millions

Tolerance analysis and structural analysis using CAD and FEA software, respectively is preferred.

Knowledge of plastics applications, associated tooling design, mold processing, and properties of plastics

Organizes Design Reviews and follows through on their completion and communicate thoughts and ideas clearly to all constituencies

Knowledge of manufacturing assembly, Quality Assurance, machine shop, plastics, metals, materials

Print reading ability, ability to figure out auxiliary views, multi-view sketching or drawing;

Metrology - ability to use calipers, micrometers, gauge pins and optical comparator.

Hands-on experience electro-mechanical systems and formed and machined parts, a plus

Experience with microfluidics or physical sciences, a strong plus


SOFTWARE REQUIREMENTS

Expertise in SolidWorks is required

COSMOSWorks, Mold Flow

Experience with MatLab and Labview, a plus

Fluent Computational Fluid Dynamics (CFD) experience is a plus

Knowledge of Microsoft Office at an Intermediate or higher level.

Location:	2006A Windy Terrace Cedar Park, TX 78613 United States