Senior Manufacturing Engineer

3 weeks ago

Waltham, United States AVAVA, Inc Full time

Job DescriptionJob Description

SUMMARY

· The Senior Manufacturing Engineer’s primary focus will be to create and maintain internal and external manufacturing procedures, processes, and fixtures used in the manufacturing of medical devices. This position will also provide critical DFM and DFT feedback during the development process. All procedures and processes must comply with FDA and ISO standards.

· This is a working position in a start-up environment and will allow the individual to build a team as the business needs arise.

ESSENTIAL DUTIES

The requirements listed below are representative of the essential duties required of the Sr Manufacturing Engineer.

· Provide DFM and DFT feedback on new products as part of the development team.

· Create product workflows and routings.

· Create work instructions for internal and external use.

· Implement process and design improvements to improve cost, time, and quality.

· Develop, implement, verify, and validate manufacturing processes in support of process flow and value stream mapping improvements for existing and new products.

· Work with quality on verification and validation procedures to support the launch of commercial manufacturing.

· Enhance manufacturing process flow and floor layout to enhance safety, quality, and efficiency.

· Work with the product development team to design manufacturing tooling and fixtures.

· Work with production and quality on creating procedures and processes to manage external contract manufacturers as well as internal production.

· Manage new product introduction and transition from product development to production.

· Lead effort to transition manufacturing of subassemblies to contract manufacturer.

· Act as the point of contact for resolving technical issues at the contract manufacturer and the production floor.

· Update work instructions, processes, and procedures as required.

· Work with development team on

· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.

SUPERVISORY RESPONSIBILITIES

· This position will build a team to support the business as required. May also be involved with managing the production floor.

SKILLS REQUIRED

Education and/or Experience

· BS in Engineering or Science required.

· Minimum of 7 years' manufacturing experience; in the medical device/FDA regulated industry. Preferably in the capital equipment and or laser field.

· Prior experience working with contract manufacturing and transitioning products from design to contract manufacturing.

· Working knowledge of the FDA, ISO, and the medical device industry requirements (e.g., FDA QSR, ISO 13485, ISO 14971)

· Good verbal and written communication skills demonstrated by ability to generate technical reports and presentations for management.

· Competent with use of Microsoft Office Suite

· Takes initiative and demonstrates leadership and teamwork.

  • Ability to work in a fast paced, dynamic startup environment.
  • Ability to work on multiple projects at the same time.
  • Ability to work with minimal supervision.
  • Strong interpersonal and communication skills.
  • Ability to work with all levels within the company.

Company DescriptionAVAVA Inc. a disruptive medical aesthetics platform company advancing a new class of focused intradermal laser products for breakthrough treatments of all skin tones, today announced that its MIRIA Skin Treatment System (“MIRIA system”) has received FDA 510(k) clearance for prevention (pre-rejuvenation) and treatment (rejuvenation) of skin aging. This marks a first of its kind regulatory clearance for a high energy focused intradermal laser, powered by Focal Point TechnologyTM, that delivers energy at any depth in the skin with pinpoint accuracy, making it ideal for patients with darker skin tones.Company DescriptionAVAVA Inc. a disruptive medical aesthetics platform company advancing a new class of focused intradermal laser products for breakthrough treatments of all skin tones, today announced that its MIRIA Skin Treatment System (“MIRIA system”) has received FDA 510(k) clearance for prevention (pre-rejuvenation) and treatment (rejuvenation) of skin aging. This marks a first of its kind regulatory clearance for a high energy focused intradermal laser, powered by Focal Point TechnologyTM, that delivers energy at any depth in the skin with pinpoint accuracy, making it ideal for patients with darker skin tones.

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