This position will be responsible for coordinating product enhancements according to customer specifications, addressing product manufacturing issues, and product lifecycle management stewardship. It requires utilizing a collaborative approach between clients, operations, production, supply chain, and the transference teams. It will also require working with a team approach by helping to improve manufacturing methods, systems and processes to produce a high-quality product at optimal cost.
**DUTIES AND RESPONSIBILITIES**:
- Coordinates product enhancements with customers and internal project teams
- Review high level design requirements to evaluate whether they are within Nextern core competency and vision
- Review design and determine required Bill of Materials
- Work with supply chain to obtain BOM pricing (from internal and external vendors)
- Draft proposals and costs models for review by management
- Responsible for Manufacturing issues as it relates to product quality and cost
- Support customer calls and presentations to compile product sustaining activities
- Help to generate all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
- Help to conduct component and device testing protocols.
- Accurately generates standard written reports.
- Help to develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
- Work with quality, supply chain and PD to ensure compliance with QSR and internal protocols.
- Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment.
- Provides support in the resolution of product complaints and/or safety issues.
- Works with various departments to facilitate pilot production of new products.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/QSR regulations.
- Transfer as required engineering project from engineering into manufacturing.
- Performs other related duties as assigned by management.
**Requirements**:
- Bachelor's degree in engineering, business administration or related fields.
- At least of 3 years of experience in similar positions in the medical devises industry or highly regulated industries
- Fully bilingual Spanish-English.
- Promote the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke, Error Proofing, Measurement System Analysis, Statistical Process Controls, Equipment Qualification, Process Qualification, Control Plan and Process Failure Mode and Effect Analysis (PFEMA)Commitment to excellence and high standards
- Among most appreciated competencies are: positive leadership and process and people focused, strong organizational, problem-solving, and analytical skills; demonstrated ability to plan and organize projects; good judgement with the ability to make timely and sound decisions; working knowledge of data collection, data analysis, evaluation, and scientific method; working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
**Benefits**
Competitive compensation package
