Manufacturing / Process Development Engineer

Job Description

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, wound healing technologies, and advanced medical devices for use in the healthcare industry. Our business is growing and we are seeking a Manufacturing / Process Development Engineer to support our increasing demand and implementation of new medical device products to market.

The qualified candidate will provide a leadership role in identifying and implementing improvements across several product manufacturing areas as well as provide a supporting role in manufacturing transfer projects. This role will interface in a collaborative team-based environment with research & development, operations, quality, regulatory, sales, and marketing teams to support and drive the successful implementation & launch of new medical devices.

There is a great amount of growth opportunity within the organization and the right candidate will have exposure to a large variety of internally manufactured products and opportunity to help shape the organization.

The responsibilities of this position include:

· Define, verify, and validate new manufacturing processes and modifications to existing products

· Perform engineering and quality analysis of processes and prototypes

· Develop and execute product/process testing protocols and document results

· Collaborate with quality and development engineering to ensure manufacturability of new medical device related products

· Develop and collaborate with automation engineers on the creation of manufacturing fixtures & equipment

· Identify and implement areas of continuous improvement for current product production

· Provide product specific technical support as needed

· Lead projects or project teams, as needed

· Understand and comply with ISO 13485, FDA, and CE requirements

· Generate and maintain all aspects of design history records per the Hemostasis Quality Management System for all engineering-based activities relate to new and existing products

Position Requirements:

· Bachelor’s degree in Manufacturing Engineering or related discipline

· Prior experience with catheter & ancillary device manufacturing and development is a plus

· Prior minimum 5 years work experience in similar engineering role in an ISO certified company, with a preference to medical device development experience

· Ability to work in a fast-paced, dynamic work environment with a focus on technical excellence, responsiveness to customer needs and innovative thinking is required

· Mechanical aptitude with the ability to understand and optimize manufacturing processes

· Strong technical writing skills: Ability to write protocols, reports, manufacturing procedures, and supporting documentation.

· Demonstrated knowledge and record of developing products within the framework of a QMS

· Critical thinking skills with the ability to solve problems and explain solutions

· Ability to manage multiple tasks simultaneously, establishing project plans and achieving timelines and communicating results

· Strong organizational skills and attention to detail

· Excellent written and oral communication skills

Hemostasis, LLC, believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives. We offer a competitive salary and benefits package including health, life, retirement and related benefits.