Product Engineer II

3 weeks ago


Billerica, United States LanceSoft Full time

JOB DESCRIPTION

As a Process Development Engineer II, you will develop new manufacturing processes, implementing and qualifying production equipment and methods, managing development builds, generating testing protocols and reports, and working to drive continuous yield improvement.
Responsibilities will include but are not limited to:
Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for yield improvement projects through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies.
Develop fixtures, tooling, and equipment.
Develop process specifications which ensure user needs are met.
Perform process characterizations and qualifications (IQ/OQ/PQ).
Manage required builds for yield improvement projects in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues.
Comply with applicable FDA and international regulatory laws/standards.
Perform other duties as assigned or required.
Nice to Have
2+ years of experience developing products and/or manufacturing processes in the medical device industry
Knowledge of SolidWorks and engineering statistics
Some experience or knowledge with Coils/Stents/Braid Manufacturing processes such as laser cutting, laser welding (similar/dissimilar materials), heat setting, electropolishing, braiding, crimping, swaging, cleaning processes, etc.
Experience with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design).
Knowledge of design and process FMECA, process validation, and process control.
Knowledge of design for manufacturability and lean methodologies.
Top 3 technical skills that are required for the role:
Validations
Project Planning
Technical Writing
Education Required:
Bachelor's degree in Engineering (preferably Mechanical, Electrical, or Biomedical)
Years' Experience Required:
2+ years of experience developing products and/or manufacturing processes in the medical device industry.
Will the contractor be working 40 hours a week? Will there be any overtime required?
Yes, 40hrs p/w with the potential of overtime.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?
Onsite fulltime
What is your timeline for scheduling interviews?
Within the next two-three weeks
What product line will this person support?
Sphere-9 Disposables

Responsibilities may include the following and other duties may be assigned. Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints. Assumes responsibility for device after transfer into highvolume production and usually responsible for entire device manufacturing operations other than wafer fabrication. May assist customer in device usage problems or customer testing of complex devices. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



  • Billerica, United States E Ink Full time

    Team up with the most innovative company where Imagination becomes reality! E Ink is the originator, pioneer, and commercial leader in ePaper technology. The Billerica Research & Development team is thriving and growing as we help develop products that are changing how people access information every day. We are seeking qualified candidates who are...


  • Billerica, United States E Ink Corporation Full time

    Team up with the most innovative company where Imagination becomes reality! E Ink is the originator, pioneer, and commercial leader in ePaper technology. The Billerica Research & Development team is thriving and growing as we help develop products that are changing how people access information every day. We are seeking qualified candidates who are...

  • Materials Engineer II

    5 months ago


    Billerica, United States Boston Materials LLC Full time

    Boston Materials produces a new class of materials that are conductive and durable like metal, yet light like plastic. The underlying technology revolves around vertically aligning carbon fibers to create materials with highly efficient energy dissipation properties. We use these highly differentiated materials to solve critical challenges relating to...


  • Billerica, Massachusetts, United States Entegee Full time

    Job OverviewWe are seeking a skilled Flowform Manufacturing Engineer to develop and maintain manufacturing processes for metal products. The ideal candidate will have experience in flowforming and proficiency in Solid Works software.ResponsibilitiesLift over 50 pounds, including overhead liftingWork flexible hours, including overtime and weekends as...


  • Billerica, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking a Machine Design Engineer with experience in ISO/AS9100 facilities, proficient in SolidWorks, GD&T, and engineering simulations.Job Requirements:Bachelor's in Mechanical Engineering or related field3-5 years of experience in Mechanical Design using SolidWorksExperience in machine-shop, aerospace, or defense...


  • billerica, United States E Ink Corporation Full time

    Team up with the most innovative company where Imagination becomes reality! E Ink is the originator, pioneer, and commercial leader in ePaper technology. The Billerica Research & Development team is thriving and growing as we help develop products that are changing how people access information every day. We are seeking qualified candidates who are...


  • Billerica, Massachusetts, United States LanceSoft Full time

    Product Development Specialist Job DescriptionJob Summary:At LanceSoft, we're seeking a highly skilled Product Development Specialist to join our team. As a key player in our product development process, you will be responsible for developing new manufacturing processes, implementing production equipment and methods, managing development builds, generating...

  • Product Manager

    4 weeks ago


    Billerica, United States Parexel International Corporation Full time

    Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do.Job Title:Product ManagerJob Introduction:At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking a Product...

  • Product Manager

    1 month ago


    Billerica, United States Parexel International Corporation Full time

    Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do.Job Title:Product ManagerJob Introduction:At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking a Product...


  • North Billerica, United States Generac Power Systems Full time

    We are Generac, a leading energy technology company committed to powering a smarter world. Over the 60 plus years of Generac’s history, we’ve been dedicated to energy innovation. From creating the home standby generator market category, to our current evolution into an energy technology solutions company, we continue to push new boundaries. Generac is a...

  • Senior Product Manager

    3 months ago


    billerica, United States E Ink Corporation Full time

    Team up with the most innovative company where Imagination becomes reality! E Ink is the originator, pioneer, and commercial leader in ePaper technology. The Billerica Research & Development team is thriving and growing as we help develop products that are changing how people access information every day. We are seeking qualified candidates who are...

  • Senior Product Manager

    3 months ago


    Billerica, United States E Ink Corporation Full time

    Team up with the most innovative company where Imagination becomes reality! E Ink is the originator, pioneer, and commercial leader in ePaper technology. The Billerica Research & Development team is thriving and growing as we help develop products that are changing how people access information every day. We are seeking qualified candidates who are...

  • Process Engineer

    3 weeks ago


    Billerica, United States Quanterix Full time

    PROCESS ENGINEER II Job ID: 171-1812 Billerica, MA Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of...


  • Billerica, Massachusetts, United States Michael Page Full time

    As a Product Development Specialist at Michael Page, you will oversee the entire product lifecycle of key product lines for this renowned medical device company. Working closely with cross-functional teams, you will develop solutions to improve medical devices and deliver exceptional products to customers.Company OverviewMichael Page is a leader in the...

  • NDT Tech II

    2 months ago


    Billerica, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking an NDT Tech II specialized in Magnetic Particle Inspection for quality and manufacturing processes.Requirements:High School Diploma or GED3-5 years experience in Quality and ManufacturingKnowledge of AQL sampling, inspecting, or testing methods, including MPIProficiency with precision measuring tools and...


  • Billerica, Massachusetts, United States BNZ Materials, Inc Full time

    Job OverviewWe are seeking a highly skilled Production Operations Manager to oversee the daily activities of our production personnel at BNZ Materials, Inc. This is a challenging role that requires strong leadership qualities and excellent communication skills.Key ResponsibilitiesThe successful candidate will be responsible for coordinating the daily...

  • Battery Engineer

    1 month ago


    Billerica, United States Factorial Energy Full time

    Job DescriptionJob DescriptionEmpowering a Sustainable FutureFactorial develops breakthrough solid-state battery technology to enable safe, scalable, and high-performance cells for electric vehicles. Our portfolio of solid-state innovations includes the segment-leading FEST® (Factorial Electrolyte System Technology), which has been scaled in 100+Ah cells,...

  • Quality Engineer

    3 months ago


    Billerica, United States Gabriele & Company Full time

    Gabriele & Company, a leading recruiting firm specializing in manufacturing and supply chain professionals, is working with a dynamic local manufacturer known for producing highly engineered, critical components utilized in Cloud, Industrial, eMobility, and medical device products. Recent growth requires the addition of a Quality Engineer, for their...

  • Quality Engineer

    2 months ago


    billerica, United States Gabriele & Company Full time

    Gabriele & Company, a leading recruiting firm specializing in manufacturing and supply chain professionals, is working with a dynamic local manufacturer known for producing highly engineered, critical components utilized in Cloud, Industrial, eMobility, and medical device products. Recent growth requires the addition of a Quality Engineer, for their...

  • Quality Engineer

    3 months ago


    Billerica, United States Gabriele & Company Full time

    Gabriele & Company, a leading recruiting firm specializing in manufacturing and supply chain professionals, is working with a dynamic local manufacturer known for producing highly engineered, critical components utilized in Cloud, Industrial, eMobility, and medical device products. Recent growth requires the addition of a Quality Engineer, for their...